Auto Suture 4216Recalls & reported problems
Covidien LP · Threaded Trocar · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521080867), received between Jul 19, 2017 and Jul 19, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Packaging Compromised” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Packaging Compromised1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2017Leak/Splash; Device Packaging Compromised; Leak/Splash; Device Packaging Compromised
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, THE SURGEON STATED THAT THE TROCAR SEAL WAS DAMAGED CAUSING AIR TO LEAK. THEY CHANGED TO ANOTHER TROCAR TO COMPLETE THE CASE. THE PATIENT STATUS IS ALIVE WITH NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6725185 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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