MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) RIGID ENDOSCOPIC GRASPING FORCEPS

Model Number	8486.621
Medical Device Problem Codes	Bent (1059); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Actual device returned to manufacturer and examined on 23feb2018.Visual inspection of forceps revealed they are bent distally and that the jaw part of the forceps is missing.Hardness test was performed on jaw part passed specifications.Most likely broke due excessive force being applied combined with normal wear and tear over time.Device approximately 9 years old.No similar complaints of broken jaw have been received on this device type 8486621.Richard wolf (b)(4) considers this matter closed.However, in the event (b)(4) receives any additional information a follow up report will be submitted to fda.(b)(4).
Event or Problem Description
Richard wolf (b)(4) was informed by the user facility that grasping forceps (id #8486.21) broke during use and the jaw part of the device still remains in the patient's carpus.User facility emailed and called to request missing/additional information, no response as of 05mar2018.Manufactured date: 28apr2009, lot size: (b)(4) units, purchase date: 10aug2009.

• Brand Name: RIGID ENDOSCOPIC GRASPING FORCEPS
• Common Device Name: GRASPING FORCEPS
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7314369
• Report Number: 9611102-2018-00001
• Device Sequence Number: 13478698
• Product Code: HRX
• UDI-Device Identifier: 04055207017692
• UDI-Public: 04055207017692
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K963022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8486.621
• Device Catalogue Number: 8486.621
• Device Lot Number: 1066632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/05/2018
• 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