MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODULAR GRASPPER FORCEPS INSERT 5MM; ERAGON MODULAR GRASPPER FORCEPS INSERT Ø 5MM

Model Number	8393293
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal part of the 8393293 eragon modular graspper forceps insert ø 5mm was evaluated and it was found that the joint part had broken off at the eye to the drawbar.The cause was due to a mechanical overload.Batch records were reviewed and it was determined that a product or production problem was not apparent.Possible hazards were considered in the risk assessment b1-2 r03 with the corresponding extent of damage and probability of occurrence and assessed with an acceptable risk.This evaluation is still valid even under consideration of the current case.The limited stability of the product is pointed out to the user in the ga-s 027 instruction manual.Several tests serve to detect possible defects and damage at an early stage.In chapter 8 control, the user is asked to carry out checks before and after each application.Do not use products that are damaged and incomplete or have loose parts.Send damaged products with the loose parts for repair.Rw (b)(4) considers this case closed; however, should additional information become available, a follow up report will be provided.
Event or Problem Description
Richard wolf (b)(4) received the following information on march 05, 2020: according to the customer: joint section broke off during the operation.The user was able to completely remove the forceps from the patient and sent it in for inspection.There is written confirmation that the incident did not lead to a serious deterioration of the patient's or third party's health, but that it did lead to a 30 minute extension of the operation.

• Brand Name: ERAGON MODULAR GRASPPER FORCEPS INSERT 5MM
• Common Device Name: ERAGON MODULAR GRASPPER FORCEPS INSERT Ø 5MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10073444
• Report Number: 9611102-2020-00004
• Device Sequence Number: 2848260
• Product Code: GEI
• UDI-Device Identifier: 04055207015995
• UDI-Public: 04055207015995
• Combination Product (Y/N): N
• PMA/510(K) Number: K981321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8393293
• Device Catalogue Number: 8393293
• Device Lot Number: 1423049
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other