VersaOne ONB12LGF (UDI 10884521181342)Recalls & reported problems
Covidien LP · Bladeless Optical Trocar with Fixation Cannula · Class 2
All models of VersaOne (47)
Data updated Oct 18, 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 10884521181342), received between Jul 11, 2016 and Mar 7, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Packaging Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2018Packaging Problem; Packaging Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE¿S OBTURATOR/TROCAR BROKE WHEREIN THE SEALING MEMBRANE OF THE TROCAR WAS RUPTURED DURING SURGERY. THE ¿SHUTTER/SWAP" BROKE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7322104 ↗MalfunctionJul 11, 2016Break; Break
ACCORDING TO THE REPORTER, DURING A THYROID LOBECTOMY, THE SELF ADJUSTING SEAL WAS BROKEN. THE DEVICE WAS NOT USED ON THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5783683 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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