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

Model Number 8486.621

Device Problems Bent (1059); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 02/09/2018

Event Type  malfunction  

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 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
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GERMANY (RWGMBH); 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7314369
• MDR Text Key: 101855358
• Report Number: 9611102-2018-00001
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04055207017692
• UDI-Public: 04055207017692
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K963022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other