ERAGON BIPOLAR 83930031Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207026526), received between Jun 29, 2020 and Nov 29, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON NOVEMBER 18, 2021 RICHARD WOLF (B)(4) WAS INFORMED BY THE DISTRIBUTOR. THE CUSTOMER HAS REPORTED THAT THE JAWS FROM THE INSERT 83930031 HAS BROKEN DURING OPERATION. THE BROKEN PART WAS FOUND ON THE GROUND FROM THE OR, IT WAS NOT IN THE BODY. NO INJURY FOR THE PATIENT. BUT THERE WAS A DELAY OF 30 MINUTES DUE TO THE RESEARCH OF THE BROKEN PIECE AND TO PERFORM RADIOSCOPY OF THE BODY. A SECOND ERAGON BIPOLAR DEVICE WAS TAKEN TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12887531 ↗
• MalfunctionAug 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE USER FACILITY, DURING THE OPERATION ON (B)(6) 2020, AGAIN A PART OF THE BRANCH OF A 83930031 GRIPPING PLIERS-INNER PART Ø 5,5MM BROKE OFF DURING AN OPERATION IN THE GYNAECOLOGICAL HOSPITAL ON THE ELBE. THE BROKEN OFF PART WAS RECOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10397484 ↗
• MalfunctionJun 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE OPERATION A PART OF THE FORCEPS BROKE OFF AND REMAINED IN THE PATIENT. THE BROKEN PART COULD ONLY BE FOUND AND RECOVERED IN A 2ND OPERATION WITH X-RAY, FOR WHICH THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER CLINIC. THE USER INFORMED US OF THE FOLLOWING: THE BRANCH OF THE BIPOLAR FORCEPS BROKE OFF WHEN A SECOND FORCEPS WAS GRASPED AND JUMPED IN THE ABDOMEN. WE SEARCHED FOR 40 MINUTES FOR THE BROKEN OFF PART AND DID NOT FIND IT. THE PATIENT WAS LAPAROSCOPED AGAIN THE SAME DAY AT THE (B)(6) UNDER X-RAY CONTROL AND THE BRANCH WAS FOUND. THE PATIENT WAS DISCHARGED ON (B)(6) 2020. CONDITION OF THE PATIENT AFTER THE APPLICATION IS VERY GOOD. THE GYNAECOLOGICAL CLINIC HAS REQUESTED THE BROKEN OFF PART FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10209329 ↗
• MalfunctionJun 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020 , A PART OF THE INSERT OF ERAGON BIPOLAR FORCEP (83930031) BROKE OFF DURING AN OPERATION IN THE GYNAECOLOGICAL HOSPITAL ON THE ELBE. THE BROKEN PART WAS RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10209320 ↗