Convertible Trocar System C0E05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915115593), received between Nov 26, 2018 and Nov 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2018Sharp Edges; Sharp Edges

  PROCEDURE PERFORMED: UNKNOWN ABDOMINAL PROCEDURE. EVENT DESCRIPTION: DISTAL EDGE OF PRODUCT SEVERELY DAMAGED LAPAROSCOPIC INSULATION ON 2 L-HOOKS. INSULATION WAS STRIPPED FROM INSTRUMENT PASSING THROUGH CANNULA AND FELL INTO ABDOMINAL CAVITY. THE OUTER DISTAL OPENING EDGE APPEARED TO BE SHARP CAUSING THE DAMAGE. HOSPITAL WILL BE REPORTING THIS TO THE HEALTH AUTHORITY. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL ON 01NOV2018: RECEIVED CLARIFICATION ON PRODUCT RETURN STATUS. IT IS NOT IMMEDIATELY AVAILABLE AS IT HAS BEEN SENT TO THEIR REGIONAL CLINICAL ENGINEERS FOR INVESTIGATION. ONCE THEIR INVESTIGATION IS COMPLETE THEY WILL BE SENDING THE INSTRUMENT BACK TO THE HOSPITAL. THE HOSPITAL WILL THEN SEND IT TO [DISTRIBUTOR ]. WE WILL THEN SEND IT TO APPLIED. THE HOSPITAL HAS CONFIRMED THAT THE PATIENT DID NOT RECEIVE ANY HARM. PATIENT STATUS: NO ADVERSE PATIENT OUTCOMES REPORTED. THE HOSPITAL HAS CONFIRMED THAT THE PATIENT DID NOT RECEIVE ANY HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102872 ↗