Convertible Trocar System C0L00Recalls & reported problems
Applied Medical Resources Corporation · Laparoscopic trocar sleeve seal · Class 2
Data updated Oct 16, 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 00607915115739), received between Feb 11, 2020 and Feb 11, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
PROCEDURE PERFORMED: LAPAROSCOPIC BOWEL RESECTION. EVENT DESCRIPTION: CMDSNET REPORT #: S-2491, MDIP 1147-SEAL WITHOUT STOPCOCK. RECURRING ISSUE MIDDLE PIECE OF BLACK RUBBER BECAME DETACHED DURING USE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16JAN2020 FROM DISTRIBUTOR: MIDDLE PIECE OF BLACK RUBBER BECAME DETACHED DURING USE. THERE WAS NO APPARENT HARM TO THE PATIENT. THIS WAS REPORTED TO CMDSNET. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16JAN2020 FROM USER FACILITY: THIS WAS A WHILE AGO SO THEY PROVIDED WHAT THEY COULD: THE PROCEDURE PERFORMED WAS A LAPAROSCOPIC BOWEL RESECTION. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY. NO APPARENT INJURY TO PATIENT ¿ THIS WAS ALSO INCLUDED IN THE REPORT PROVIDED TO SOUTHMEDIC. INSTRUMENTATION BEING USED AT THE TIME OF THE INCIDENT WAS ENDOSCOPIC [] GRASPER. THE ENTIRE COMPONENT FELL OUT. NO PIECES FELL INTO PATIENT. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD AND RETAINED OFF. TYPE OF INTERVENTION: ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD. PATIENT STATUS: NO APPARENT PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9694296 ↗
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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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