N/A LF2019Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327565317), received between Aug 26, 2024 and Aug 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING A SURGICAL CASE TODAY TWO DEVICES WERE NOT WORKING AS EXPECTED. DEVICE DID NOT RECOGNIZE IN GENERATOR, SHOWING AN ERROR MESSAGE THAT WOULDN'T ALLOW ANY SEALING TO HAPPEN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20064303 ↗MalfunctionAug 26, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING A SURGICAL CASE TODAY TWO DEVICES WERE NOT WORKING AS EXPECTED. DEVICE DID NOT RECOGNIZE IN GENERATOR, SHOWING AN ERROR MESSAGE THAT WOULDN'T ALLOW ANY SEALING TO HAPPEN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20064296 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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