ERAGON MODULARRecalls & reported problems across all models
Richard Wolf GmbH · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 16 models of ERAGON MODULAR by Richard Wolf GmbH in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2017 and Aug 11, 2026 — classified as 9 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Break” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ERAGON MODULAR problems
Device problems
- Break7
- Insufficient Device Problem Information5
- Detachment of Device or Device Component4
- Material Fragmentation4
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available2
- Mechanical Problem2
- Use of Device Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient7
- Foreign Body In Patient4
- Bowel Perforation3
- Burn(s)3
- Device Embedded In Tissue or Plaque3
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
ERAGON MODULAR models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ERAGON MODULAR 8393249Laparoscope, general & plastic surgery5 reports
- ERAGON MODULAR 8393293ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- ERAGON MODULAR 8393041Laparoscope, general & plastic surgery3 reports
- ERAGON MODULAR 8393933Laparoscope, general & plastic surgery3 reports
- ERAGON MODULAR 8393184Laparoscope, general & plastic surgery2 reports
- ERAGON MODULAR 83930074Laparoscope, general & plastic surgery2 reports
- ERAGON MODULAR 8393044Laparoscope, general & plastic surgery1 report
- ERAGON MODULAR 8393185Laparoscope, general & plastic surgery1 report
- ERAGON MODULAR 8393189ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- ERAGON MODULAR 8393190Laparoscope, general & plastic surgery1 report
- ERAGON MODULAR 8393292Laparoscope, general & plastic surgery1 report
- ERAGON MODULAR 8395214FORCEPS, GENERAL & PLASTIC SURGERY1 report
- ERAGON MODULAR 83930072Laparoscope, general & plastic surgery1 report
- ERAGON MODULAR 83930073Laparoscope, general & plastic surgery1 report
- ERAGON MODULAR 8394258Laparoscope, general & plastic surgery1 report
- ERAGON MODULAR 83932297Laparoscope, general & plastic surgery1 report
Recent ERAGON MODULAR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Material Fragmentation
It was reported that during laparoscopic surgery while moving bowel, a small metal piece of the grasper fell off. An X-Ray was taken and the missing piece was visualized. However, it was unable to be removed. The Port site extended, and the small piece of the grasper was located. The Bowel resection completed.
Patient problems: Insufficient Information
MAUDE report 50201456 ↗InjuryAug 11, 2026Material Fragmentation
It was reported that during laparoscopic surgery, the grasper broke inside of patient while grasping a piece of bowel to hold and retract it. Two pieces were located and removed at that time. A third piece was determined to be missing and unable to be located.An X-Ray was taken and the Third piece was visualized. However, it was unable to be removed via the laparoscopic surgery. Therefore, the procedure was converted to an open resection, and the third piece was removed. The bowel resection was completed.
Patient problems: Insufficient Information
MAUDE report 50201451 ↗InjuryJun 24, 2026Insufficient Device Problem Information
ACCORDING TO THE REPORT, THE FORCEPS HAVE CAUSED TRAUMATIC LESIONS, SOME OF WHICH WITH TRANSMURAL PERFORATION. PATIENT REQUIRING SURGICAL RE-INTERVENTION DUE TO SMALL BOWEL PERFORATIONS. THE USER DID NOT SPECIFY WHETHER A MALFUNCTION OCCURRED WHILE THE FORCEPS WERE BEING USED OR EXACTLY WHAT CIRCUMSTANCES LED TO THE PATIENT'S INJURY.
Patient problems: Bowel Perforation
MAUDE report 25607356 ↗InjuryJun 24, 2026Insufficient Device Problem Information
ACCORDING TO THE REPORT, THE FORCEPS HAVE CAUSED TRAUMATIC LESIONS, SOME OF WHICH WITH TRANSMURAL PERFORATION. PATIENT REQUIRING SURGICAL RE-INTERVENTION DUE TO SMALL BOWEL PERFORATIONS. THE USER DID NOT SPECIFY WHETHER A MALFUNCTION OCCURRED WHILE THE FORCEPS WERE BEING USED OR EXACTLY WHAT CIRCUMSTANCES LED TO THE PATIENT'S INJURY.
Patient problems: Bowel Perforation
MAUDE report 25607345 ↗InjuryMar 19, 2026Break
IT WAS REPORTED THAT THE SURGEON WAS PERFORMING AN ABDOMINAL SURGERY WHEN THE INSTRUMENT BROKE. A SEARCH OF THE SURROUNDING SURGICAL SITE AND THE OPERATING ROOM WAS INITIATED. SINCE THE PIECE COULD NOT BE FOUND, AN X-RAY EXAMINATION WAS PERFORMED, AND THE RISK MANAGEMENT FORM WAS COMPLETED IN ACCORDANCE WITH HOSPITAL GUIDELINES. THE SURGEON INFORMED THE PATIENT ONE DAY AFTER THE SURGERY. THE OPERATION WAS COMPLETED WITHOUT HARM TO THE PATIENT. HOWEVER, THE BROKEN PIECE WAS NOT DETECTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24640357 ↗InjuryAug 13, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE JOINT HINGE OF ONE ARM OF THE BABCOCK FORCEPS BROKE OFF. IT FELL INTO THE SURGICAL SITE AND COULD NOT BE RETRIEVED EVEN WITH THE AID OF A C-ARM MACHINE. THE SURGERY WAS EXTENDED BY APPROXIMATELY AN HOUR.
Patient problems: Foreign Body In Patient
MAUDE report 22798076 ↗MalfunctionFeb 15, 2023Material Twisted/Bent; Material Twisted/Bent
THE USER FACILITY CLAIMED THAT "WE WERE FACED WITH THE SAME PROBLEM WITH 2 METZENBAUM SCISSOR INSERTS (REF: 8393.041) DELIVERED ON (B)(6). DURING OPERATIONS, THE JAWS OF THE SCISSORS BECAME UNSUITABLE. ONE OF THEM WAS USED ONCE, THE OTHER WAS USED THREE TIMES. THEY ARE PART OF THE SAME BATCH (1516371)." THERE WAS NO HARM TO THE PATIENT AND NO COMPONENT OF THE SCISSORS WAS LOST. THE TREATMENT WAS COMPLETED WITH ANOTHER PAIR OF SCISSORS, BUT THERE WAS A SURGERY DELAY OF 1 HOUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16380840 ↗MalfunctionDec 27, 2022Material Fragmentation; Material Fragmentation
RICHARD WOLF GMBH REFERENCE: (B)(4). RICHARD WOLF GMBH IN KNITTLINGEN /MANUFACTURER WAS INFORMED ABOUT THE FOLLOWING: DESCRIPTION OF INCIDENT/CLAIM: ITEM 8393249 LOT 4500250452, INSTRUMENT WAS BEING USED FOR A LAPAROSCOPIC BOWEL CASE. ONCE THE CASE HAD FINISHED THE SCRUB NURSE REALIZED THAT AN INSTRUMENT WAS DAMAGED AND THAT A PIECE WAS MISSING. AFTER AN XRAY OF THE PATIENT THE MISSING PIECE WAS LOCATED IN THE PATIENT WHO WAS SUBSEQUENTLY RE-OPENED AND THE PIECE WAS REMOVED. PATIENT HAD TO RETURN TO THEATRE AND BE ANESTHETIZED FOR A 2ND TIME TO REMOVE BROKEN ITEM. RWGMBH MDR AWARENESS DATE: (B)(6) 2022
Patient problems: Foreign Body In Patient
MAUDE report 16055635 ↗MalfunctionDec 19, 2022Deformation Due to Compressive Stress; Difficult to Open or Close; Deformation Due to Compressive Stress; Difficult to Open or Close
RICHARD WOLF GMBH REFERENCE: (B)(4). RICHARD WOLF GMBH IN (B)(4) (MANUFACTURER) WAS INFORMED ABOUT THE FOLLOWING: DESCRIPTION OF INCIDENT/CLAIM: THE RESPECTIVE 5MM GRASPING FORCEPS WAS APPLICATED DURING A THORASCOPICAL RESECTION. AFTER GRASPING OF LUNGS TISSUE WITH ACTIVATED LOCK THE LOCK COULD NOT BE DEACTIVATED AGAIN. AS A CONSEQUENCE THE TISSUE IN THE JAWS HAD TO BE CUT OUT, SO THE FORCEPS COULD RECOVERED AGAIN. THE TREATMENT COULD BE COMPLETED WITHOUT ANY SIGNIFICANT DELAY. THE PATIENT'S CONSEQUENCE WAS DESCRIBED AS "GOOD". DUE TO THE PATIENT INJURY AND A POTENTIAL SERIOUS INCIDENT IF THE CASE WOULD REOCCUR, THE CASE IS DETERMINED AS REPORTABLE. THIS CASE WAS REPORTED BY THE USER TO THE GERMAN AUTHORITIES. RWGMBH MDR AWARENESS DATE: 10-OCT--2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16005306 ↗MalfunctionSep 23, 2022Mechanical Problem; Mechanical Problem
RICHARD WOLF GMBH REFERENCE COMPLAINT (B)(4) (FU1 MDR / ADDITIONAL INFORMATION - DEVICE NOT RETURNED) THE PURPOSE OF THIS SUBMISSION IS TO REPORT THAT DEVICE EVALUATION IS NOT AVAILABLE DUE TO DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION. (SEE H10) DEVICE NOT RETURNED: RWGMBH AWARENESS DATE, 18-JAN-2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15473878 ↗MalfunctionSep 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). USER REPORT MV-2002-00463 IN FRANCE. THE USER HAS REPORTED THE FOLLOWING: GRIPPING FORCEPS TOO TRAUMATIC FOR THE SMALL INTESTINE AND DIGESTIVE TRACT REPEATED WOUNDS, REQUIRING MODIFICATION OF THE PROCEDURE, SUTURES ETC... CLINICAL CONSEQUENCE: PERITONITIS, RECOVERY, MAJOR RISK. RWGMBH AWARENESS DATE, 22-AUG-2022.
Patient problems: Peritonitis; Wound Dehiscence
MAUDE report 15455463 ↗MalfunctionJul 1, 2022Detachment of Device or Device Component; No Apparent Adverse Event; Insufficient Device Problem Information; Detachment of Device or Device Component; No Apparent Adverse Event; Insufficient Device Problem Information
RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). ON JUNE 14, 2022 RICHARD WOLF GMBH WAS INFORMED ABOUT THE FOLLOWING: DURING LAPAROSCOPIC PROSTATE RESECTION, AFTER INTERNAL ORGAN EXCLUSION WHEN THE DOCTOR REMOVED THE FORCEPS VIA TROCAR, THE JAW PART OF THE INSERT WAS COMPLETELY BROKEN. NO INITIAL INFORMATION OF THE COMPONENT OF THE JAW PART, SUCH AS PIN, IT WAS IMPOSSIBLE TO KNOW ALL BROKEN PARTS WERE COLLECTED. THE USER PERFORMED AN X-RAY BUT COULD NOT CONFIRM IF ANYTHING REMAINED IN THE BODY. THE TREATMENT COULD BE COMPLETED WITH A REPLACEMENT INSTRUMENT. FURTHERMORE; THE USER STATED THAT THERE IS NO HEALTH HAZARD FOR THE PATIENT. RWGMBH AWARENESS DATE, 14-JUN-2022.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 14887648 ↗MalfunctionMay 20, 2021Material Separation; Material Separation
RW MIC RECEIVED A RESPONSE FROM THE USER FACILITY WITH ADDITIONAL INFORMATION: PROCEDURE: ROBOTIC LOW ANTERIOR RESECTION AND CREATION OF DIVERTING LOOP ILEOSTOMY, FLEXIBLE SIGMOIDOSCOPY. DEVICE FAILURE HAPPENED WHILE THE INSTRUMENT WAS BEING USED INTRAOPERATIVELY. THIS WAS AFTER THE PATIENT WAS ASLEEP AND INSUFFLATION WAS COMPLETE. THIS WAS A ROBOTIC CASE SO WE WERE USING TROCHARS, SCOPE, ELECTROCAUTERY GENERATOR AND CAMERA. THE DEVICE WAS RETURNED TO RICHARD WOLF AND A VISUAL INSPECTION WAS COMPLETED. THE INVESTIGATION FOUND THAT ONE SIDE OF THE FORK, WHICH ENCLOSES THE HINGES, IS BROKEN OFF AND IS NOT PRESENT. ALSO MISSING ARE AT LEAST TWO CONNECTING PINS AND TWO GUIDE PINS. IT SEEMS THAT A LOT OF LATERAL FORCE WAS APPLIED TO THE JAWS, WHICH CAUSED THE FORK TO BREAK. THESE ARE RELATIVELY LONG JAWS, AND THIS LEVERAGE CAN CREATE A LOT OF INTERNAL STRAIN. CARE MUST BE TAKEN NOT TO OVERLOAD THE DELICATE COMPONENTS. THE ROOT CAUSE WAS ATTRIBUTED TO HUMAN ERROR. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11855436 ↗MalfunctionApr 20, 2021Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
IT WAS REPORTED TO RICHARD WOLF (B)(4): THE CUSTOMER REPORTED THE FOLLOWING INCIDENT TO HEALTH (B)(6). DURING A LAPAROSCOPIC SURGERY, THE WOLF DUAL ACTION BOWEL GRASPER BROKE INSIDE THE PATIENT. THIS OCCURRED DURING ROTATION OF THE INSTRUMENT. THIS RESULTED IN THE PATIENT REQUIRING A LAPAROTOMY TO REMOVE THE INSTRUMENT, AND THE INSTRUMENT BEING DISMANTLED INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11697252 ↗MalfunctionMar 29, 2021Flaked; Flaked
THE USER FACILITY REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS THAT ON (B)(6): DURING A GALL BLADDER PROCEDURE THIS MORNING, ONE OF THE GRASPERS THE SURGEON WAS USING, WHICH WAS THE BLUNT GRASPER, WHEN HE PUT IN THROUGH THE TROCAR THE COATING FROM THE SHEATH OF THE GRASPER FLAKED OFF INTO THE PATIENT'S CAVITY. HE STATED HE THOUGHT HE WAS ABLE TO SUCK OUT MOST OF IT AND IRRIGATED THE PATIENT'S ABDOMEN. HE IS NOT PLEASED WITH THE INSTRUMENTS AT THIS POINT. THIS OF COURSE IS A SAFETY ISSUE USING THE GRASPERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581324 ↗
Other Richard Wolf GmbH products
All Richard Wolf GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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