NA 8383423Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04055207015001), received between Apr 8, 2019 and Apr 6, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Material Disintegration; Material Disintegration

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A HOOK ELECTRODE MONO Ø 5MM WL 340MM, PART ID: 8383423, BATCH # 1460860. ACCORDING TO THE RECEIVED INFORMATION: "SURGERY: LAPAROSCOPY FOR ACUTE CHOLECYSTITIS MONOPOLAR CURRENT AT 30 ALL THE TIME OF THE INTERVENTION - HEMOSTASIS MADE WITH BIPOLAR FORCEPS NOT RESULTING FROM AN EXCESSIVE MONOPOLAR CURRENT. INCIDENT: DURING THE INTERVENTION, OBSERVATION OF A MISSING PART, WHICH PROBABLY FELL INTO THE PATIENT, WITHOUT IT BEING FORMALLY FOUND (PERHAPS SUCKED UP DURING WASHING). NO VISIBLE INJURIES BUT STILL A FEAR THAT THE MISSING PART OF THE HOOK WAS NOT ASPIRATED DURING THE INTERVENTION AND THEREFORE REMAINED IN THE PATIENT. NO OTHER CONSEQUENCES."

  Patient problems: Insufficient Information

  MAUDE report 16694005 ↗
• MalfunctionDec 21, 2022Overheating of Device; Insufficient Device Problem Information; Overheating of Device; Insufficient Device Problem Information

  RICHARD WOLF GMBH REFERENCE: (B)(4). RICHARD WOLF GMBH IN KNITTLINGEN (MANUFACTURER) WAS INFORMED ABOUT THE FOLLOWING: DESCRIPTION OF INCIDENT/CLAIM ACCORDING TO THE CUSTOMER: "DURING SURGERY (LAPAROSCOPY FOR CHOLECYSTECTOMY), MELTING OF THE SHEATH WHICH GENERATED AN ACCIDENTAL BURN ON THE STOMACH." THE INSTRUMENT WAS REPLACED AND THE TREATMENT COULD BE COMPLETED. RWGMBH MDR AWARENESS DATE: 05-DEC-2022.

  Patient problems: Gastroesophageal Burn; Insufficient Information

  MAUDE report 16026822 ↗
• MalfunctionOct 8, 2021Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. SEE MANUFACTURERS NARRATIVE.

  Patient problems: Gastroesophageal Burn

  MAUDE report 12598689 ↗
• MalfunctionJun 11, 2021Peeled/Delaminated; Peeled/Delaminated

  THE PURPOSE OF THIS REPORT IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION, SEE MANUFACTURERS NARRATIVE AT THE END.

  Patient problems: Bowel Burn

  MAUDE report 11983731 ↗
• MalfunctionJul 3, 2019Sparking; Sparking

  ON (B)(6) 2019, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): THE CABLE SPARKED DURING THE PROCEDURE. NO PATIENT INJURY. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? NO. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? GENERAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757859 ↗
• MalfunctionApr 8, 2019Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2019 RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A REPORT FROM RICHARD WOLF GMBH (GMBH) REPORTING THE FOLLOWING: UNDETECTED LOSS OF THE TIP OF THE MEDICAL DEVICE IN THE ABDOMEN. THE INDICATION OF THE LACK OF THE TIP WAS DETECTED AFTER THE SURGERY DURING THE RE-STERILIZATION OF THE DEVICE. A DIRECT ABDOMINAL X-RAY ALLOWED TO DETECT THE PRESENCE OF THE TIP IN THE ABDOMEN. CURRENTLY PATIENT INJURY IS UNKNOWN, QUESTIONNAIRE HAS BEEN SENT TO THE INITIAL REPORTER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8493295 ↗