Versaport ONB11LGFRecalls & reported problems
Covidien LP · Bladeless Optical Trocar with Fixation Cannula · Class 2
All models of Versaport (21)
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 10884521181380), received between Jul 9, 2019 and Apr 14, 2022 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Leak/Splash1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2022Break; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PYELOTOMY PROCEDURE, WHEN CHANGING THE DOOR ANGLE TO DISSECTION CLAMP, THE TROCAR BEGAN TO SPILL OUT. WHEN OBSERVED, THE MEMBRANE WAS BROKEN. THE PRODUCT WAS CHANGED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14112500 ↗MalfunctionJul 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WHEN DOING THE SURGICAL STAPLING, THE SEAL OF THE TROCAR WAS DISENGAGED AND THE RUBBER ENDED UP BURSTING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8773703 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page