- This study reviewed the FDA Manufacturer and User Facility Device Experience database for malfunctions of surgical staplers, clip appliers, implantable staples, and implantable clips that resulted in patient death between 1992 and 2016
- During the study period, 676 reported deaths were associated with the use of these devices: 76% occurred postoperatively, 12% were intraoperative, and for 12%, the timing was not reported
- For 325 postoperative deaths (48%), no device malfunction was evident intraoperatively
- After adjustment for annual changes in surgical volume, the occurrence of device-related mortality significantly increased during the study period, overall (slope=2.7; P<0.001) and for gastrointestinal, hepatic, kidney, and spleen procedures
- A high index of suspicion in postoperative management is crucial when these devices are used so any complications related to malfunction can be addressed early
There's growing conflict between surgeons, device manufacturers, and the FDA about the safety of surgical staplers (SS) and clip appliers (CA). Several years ago, investigative journalists filed a Freedom of Information Act request to obtain data from the FDA Alternative Summary Reporting database, which is inaccessible to the public and outside researchers.
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In March 2019, they reported in Kaiser Health News that thousands of nonfatal, yet often injurious, SS and CA malfunctions were being concealed because they could be reported to the alternative database instead of the publicly accessible FDA Manufacturer and User Facility Device Experience (MAUDE) database.
The FDA immediately issued a Letter to Health Care Providers to announce an ongoing internal analysis. In the meantime, Matthew F. Wszolek, MD, chair of Quality and Safety in the Department of Urology at Massachusetts General Hospital, and colleagues reviewed the MAUDE database from 1992 to 2016. They analyzed reports on SS, CA, and implantable staples and clips (collectively called SS/CA).
In Surgery, the researchers say they expected to find decreased mortality related to SS/CA malfunction due to improvements in product design and increased surgeon experience. Instead, although rare, mortality significantly increased during the study period.
Incidence and Timing of Mortality
The researchers found reports in MAUDE on 75,415 reported malfunctions, 21,115 serious injuries, and 676 deaths associated with using SS/CA. Only malfunctions that result in death are required to be reported, so they focused on those:
- Gastrointestinal (54%), thoracic (22%), and hepatic/kidney/spleen surgery (11%) were the procedures most commonly associated with mortality related to SS/CA failure
- 516 deaths (76%) occurred postoperatively, 12% were intraoperative, and for 12%, the timing was not reported
- Postoperative deaths were most commonly attributed to infection/sepsis (17%) or vascular injuries (21%); the vast majority of intraoperative deaths were related to vascular injuries (92%)
Recognition of Device Failure
Of the 676 patients who died:
- 268 (40%) had SS/CA failure recognized intraoperatively; 30% of them died intraoperatively, 57% died postoperatively, and time of death was not reported for 13%
- 325 (48%) had no device malfunction evident intraoperatively and died postoperatively; failure was diagnosed on postoperative intervention or diagnostic testing
- 83 (12%) had no information reported about when device failure was recognized
After adjustment for annual changes in surgical volume, the overall occurrence of SS/CA-related mortality significantly increased during the study period (slope=2.7; P<0.001). In subgroup analysis, the same was true for gastrointestinal, hepatic, kidney, and spleen procedures but not for cardiac or thoracic surgery.
Implications for Clinicians and Administrators
A high index of suspicion in postoperative management is crucial when SS/CA are used so any malfunction-related complications can be addressed early.
Hospitals should ensure adequate training in using these devices, accurate and consistent reporting of failures, and preservation/study of malfunctioning devices. Disposal or reuse before testing may have medicolegal consequences.
Recent FDA Action
In October 2021, the FDA issued updated guidance and sent another Letter to Health Care Providers about the safe use of SS and implantable staples. As part of the updated guidance, it reclassified the devices from class I to class II with special controls.
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