MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) GRASPING FORCEPS INSERT 0.5MM; INSERT, FORCEPS

Model Number	8393.705
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Facility contacted richard wolf medical instruments corporation (b)(4) and relayed that during a procedure a piece of wire on the device in question fell off into patient.An x-ray was performed in order to locate and retrieve foreign object.Once retrieved a back up device was used to complete procedure.No injury to patient reported.The delay in locating and retrieving foreign object may have placed patient at risk.Manufacture date - oct2009 (7 1/2 years old).No similar issues report on this device in the last three years.Request for additional/missing information has been sent to user facility, no response as of 15may2017.Device received at (b)(4) (importer) on 21apr2017.Device to be sent to richard wolf (b)(4) (manufacturer) on 17may2017 for investigation.(b)(4) considers this matter closed.However, in the event (b)(4) receives any additional information, (b)(4) will provide (b)(4) (manufacturer) with follow-up information.
Additional Manufacturer Narrative
Follow up #1.The following sections updated/added: product problem, suspect device, importer (device), corrected data.Richard wolf medical instruments cooperation (rwmic) received investigation results from manufacturer on 01dec2017.Visual inspection of device found the weld seam on both sides of the sector part was broken and appears to be caused by mechanical overloading due to user.The 8393705 grasp.Forceps insert 5mm from batch 249o09 was produced in october 2009 and consisted of (b)(4) pieces.The production run plan was checked - no deviations.Since there are no signs of a product problem, further measures are not required.Instructions for use ga-e194 / de / 2016-05 v6.0 / pdi 16-8410 contain the following applicable warnings: it is noted at several points in the instructions for use to be carried out checks.Controls should be performed before and after each application.Do not use products that are damaged, incomplete or loose.Potential hazards were taken into account in the risk assessment for risk assessment (b)(4) (reusable non-optical forceps and scissors) with the corresponding extent of damage and probability of occurrence, and assessed with an acceptable risk.This rating is still valid considering the current case.Rwmic considers this matter closed.However, in the event rwmic receives any additional information a follow up report will be submitted to fda.
Event or Problem Description
Follow up #1.

• Brand Name: GRASPING FORCEPS INSERT 0.5MM
• Common Device Name: INSERT, FORCEPS
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6566711
• Report Number: 1418479-2017-00009
• Device Sequence Number: 10966541
• Product Code: GEI
• UDI-Device Identifier: 04055207016183
• UDI-Public: 04055207016183
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017
• Report Date (Section F): 12/21/2017

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: Physician
• Device Model Number: 8393.705
• Device Lot Number: 249O09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/19/2017
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE; HF CABLE
• Date Report Sent to FDA: 12/21/2017