Convertible Trocar System C0415Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915114367), received between Aug 14, 2018 and Aug 14, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (5 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2018Sharp Edges; Sharp Edges

  PROCEDURE PERFORMED: UNKNOWN. ACCORDING TO TELEPHONE INFORMATION, THE SLEEVE OF THE TROCAR IS VERY SHARP. THIS DAMAGED THE INSULATION OF OTHER INSTRUMENTS. ADDITIONAL INFORMATION RECEIVED BY PHONE FROM SALES REPRESENTATIVE ON 25MAY2018: THERE ARE PHOTOS AVAILABLE, WHICH WILL BE SENT SOON. THIS AND 4 ADDITIONAL EVENT UNITS ARE BEING RETURNED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783470 ↗
• MalfunctionAug 14, 2018Sharp Edges; Sharp Edges

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: ACCORDING TO TELEPHONE INFORMATION, THE SLEEVE OF THE TROCAR IS VERY SHARP. THIS DAMAGED THE INSULATION OF OTHER INSTRUMENTS. ADDITIONAL INFORMATION RECEIVED BY PHONE FROM SALES REPRESENTATIVE ON 25MAY2018: THERE ARE PHOTOS AVAILABLE, WHICH WILL BE SENT SOON. THIS AND 4 ADDITIONAL EVENT UNITS ARE BEING RETURNED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783431 ↗
• MalfunctionAug 14, 2018Sharp Edges; Sharp Edges

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: ACCORDING TO TELEPHONE INFORMATION, THE SLEEVE OF THE TROCAR IS VERY SHARP. THIS DAMAGED THE INSULATION OF OTHER INSTRUMENTS. ADDITIONAL INFORMATION RECEIVED BY PHONE FROM SALES REPRESENTATIVE ON 25-MAY-2018: THERE ARE PHOTOS AVAILABLE, WHICH WILL BE SENT SOON. THIS AND 4 ADDITIONAL EVENT UNITS ARE BEING RETURNED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783429 ↗
• MalfunctionAug 14, 2018Sharp Edges; Sharp Edges

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: ACCORDING TO TELEPHONE INFORMATION, THE SLEEVE OF THE TROCAR IS VERY SHARP. THIS DAMAGED THE INSULATION OF OTHER INSTRUMENTS. ADDITIONAL INFORMATION RECEIVED BY PHONE FROM SALES REPRESENTATIVE ON 25MAY2018: THERE ARE PHOTOS AVAILABLE, WHICH WILL BE SENT SOON. THIS AND 4 ADDITIONAL EVENT UNITS ARE BEING RETURNED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783400 ↗
• MalfunctionAug 14, 2018Sharp Edges; Sharp Edges

  PROCEDURE PERFORMED: UNKNOWN. ACCORDING TO TELEPHONE INFORMATION, THE SLEEVE OF THE TROCAR IS VERY SHARP. THIS DAMAGED THE INSULATION OF OTHER INSTRUMENTS. ADDITIONAL INFORMATION RECEIVED BY PHONE FROM SALES REPRESENTATIVE ON 25MAY2018: THERE ARE PHOTOS AVAILABLE, WHICH WILL BE SENT SOON. THIS AND 4 ADDITIONAL EVENT UNITS ARE BEING RETURNED. NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783393 ↗