FIBRA® / FIBRA CLAMP INSERT G-8655Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915111298), received between Jun 25, 2016 and Apr 5, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (2 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 18, 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.

• MalfunctionApr 5, 2017Fitting Problem; Fitting Problem

  "ON (B)(6) 2017" "WHEN A MEDICAL STAFF TRIED TO ATTACH THE INSERT TO A CLAMP, THE MEDICAL STAFF FOUND THAT THE ATTACHED BUTTONS OF THE INSERT WERE DEFORMED AND DIDN'T ATTACH TO THE CLAMP. ANOTHER PACKAGE OF INSERT WAS OPENED AND USED FOR THE SURGERY." COMMENTS FROM (B)(6): "ONE (1) UNIT OF INSERT WAS RETURNED FROM THE HOSPITAL. WE CONFIRMED THE DEVICE AND FOUND THAT THE ATTACHMENT BUTTONS WERE SHAVED. THE SAMPLE WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." TYPE OF INTERVENTION: "ANOTHER PACKAGE OF INSERT WAS OPENED AND USED FOR THE SURGERY." PATIENT STATUS: THIS EVENT DIDN'T AFFECT THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6461934 ↗
• MalfunctionFeb 8, 2017Fitting Problem; Fitting Problem

  PROCEDURE UNKNOWN: THE INSERTS SEEMED TO APPROXIMATE TIGHTLY AT THE PROXIMAL END OF THE CLAMP JAWS BUT THE DISTAL END WAS SLIGHTLY GAPPED. WE HAVE ORDERED 2 NEW V. MUELLER CLAMPS AND ONE SEEMS TO WORK WITH THE INSERTS AND ONE DOESN'T. THESE INSERTS WERE USED IN A PROCEDURE BUT I'M NOT SURE IF THEY WERE FROM THE SAME LOT OR NOT. PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6312195 ↗
• MalfunctionAug 9, 2016Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: ON (B)(6) 2016 DURING A PREPARATION FOR A SURGERY; TRIED TO ATTACH THE INSERT TO A CLAMP, THE INSERT WAS NOT ATTACHED CORRECTLY TO THE CLAMP AND THERE IS A SPACE BETWEEN THE INSERT AND THE CLAMP. ANOTHER PACK OF INSERT WAS USED FOR THE SURGERY. NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT. COMMENTS FROM COSMOTEC： ONE (1) UNIT OF INSERT WAS RETURNED FROM THE HOSPITAL. WE CONFIRMED THE DEVICE AND FOUND THAT SOME OF THE ATTACHMENT BUTTONS WERE SHAVED. THE SAMPLE WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." TYPE OF INTERVENTION: "UNKNOWN." PATIENT STATUS: "NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5861182 ↗
• MalfunctionJun 25, 2016Misconnection; Misconnection

  PROCEDURE PERFORMED: UNKNOWN, IT WAS DURING DEVICE USE CHECK BEFORE STARTING AN OPERATION. DURING DEVICE USE CHECK BEFORE STARTING AN OPERATION: A NURSE TRIED TO ATTACH THE INSERT TO A CLAMP MADE BY APPLIED MEDICAL. UNFORTUNATELY THE INSERT. WAS NOT ATTACHED TO AND FELL OFF FROM THE CLAMP. ANOTHER PACK OF INSERT FROM THE SAME LOT WAS OPENED. HOWEVER, THE SECOND PAIR OF INSERT WAS NOT ATTACHED TO AND FELL OFF AGAIN. ANOTHER PACK OF INSERT FROM THE SAME LOT WAS OPENED FOR THE THIRD TRY. THE THIRD PAIR OF INSERT WAS SUCCESSFULLY ATTACHED AND USED FOR THE OPERATION. THERE WAS NO IMPACT TO THE OPERATION. NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. COMMENTS FROM COSMOTEC: "TWO (2) UNITS OF INSERT WERE RETURNED FROM THE CUSTOMER. WE CONFIRMED THE DEVICES AND FOUND THAT SOME OF THE ATTACHMENT BUTTONS WERE SHAVED. THE SAMPLES WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." ADDITIONAL INFO RECEIVED: JUNE 15, 2016: WHAT CLAMP WAS BEING USED WITH THESE INSERTS? -THE CUSTOMER USED A CLAMP MADE BY APPLIED MEDICAL WITH THE COMPLAINT INSERTS. TYPE OF INTERVENTION - "N/A". PATIENT STATUS - "NO HEALTH DAMAGE HAS B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5749466 ↗
• MalfunctionJun 25, 2016Misconnection; Misconnection

  PROCEDURE PERFORMED: UNKNOWN, IT WAS DURING DEVICE USE CHECK BEFORE STARTING AN OPERATION. DURING DEVICE USE CHECK BEFORE STARTING AN OPERATION: A NURSE TRIED TO ATTACH THE INSERT TO A CLAMP MADE BY APPLIED MEDICAL. UNFORTUNATELY THE INSERT. WAS NOT ATTACHED TO AND FELL OFF FROM THE CLAMP. ANOTHER PACK OF INSERT FROM THE SAME LOT WAS OPENED. HOWEVER, THE SECOND PAIR OF INSERT WAS NOT ATTACHED TO AND FELL OFF AGAIN. ANOTHER PACK OF INSERT FROM THE SAME LOT WAS OPENED FOR THE THIRD TRY. THE THIRD PAIR OF INSERT WAS SUCCESSFULLY ATTACHED AND USED FOR THE OPERATION. THERE WAS NO IMPACT TO THE OPERATION. NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. COMMENTS FROM COSMOTEC: "TWO (2) UNITS OF INSERT WERE RETURNED FROM THE CUSTOMER. WE CONFIRMED THE DEVICES AND FOUND THAT SOME OF THE ATTACHMENT BUTTONS WERE SHAVED. THE SAMPLES WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." ADDITIONAL INFO RECEIVED: JUNE 15, 2016. WHAT CLAMP WAS BEING USED WITH THESE INSERTS? -THE CUSTOMER USED A CLAMP MADE BY APPLIED MEDICAL WITH THE COMPLAINT INSERTS. PATIENT STATUS: "NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5749465 ↗