MAUDE Adverse Event Report: RICHARD WOLF GMBH RONGEUR

Model Number 8792.636

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Richard wolf medical instruments (b)(4) was notified by richard wolf medical instruments corp usa (rwmic) of a break of a rongeur.The grasping claws on device broke during the procedure and half of the claws fell into patient.The piece was unable to be retrieved.In order to complete the procedure, a backup device was used.No consequences to patient or staff has been reported.

Manufacturer Narrative

An investigation has not been completed as the actual device was not returned to rw(b4) as of 12/11/2014.Device is currently in transit to rw(b)(4).Richard wolf medical instruments (b)(4) considers this matter open.Device is currently in transit to (b)(4) for investigation.Once the device is received and additional information is available, a follow-up report will be provided.

Manufacturer Narrative

Visual examination revealed jaw was broken at the hinge region.Excessive force was used on device.Root cause is user error.The instrument has signs of unauthorized repairs.Instructions for use have been reviewed and considered adequate as there is a warning about excessive force.Rwgmbh considers this matter closed.In the event add'l info is received by rwgmbh, a f/u report will be sent to fda.

• Brand Name: RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer str. 32; GM
• Manufacturer Contact: dawn clark ; pforzheimer str. 32; knittlingen 75438 ; GM 75438 ; 8479558016
• MDR Report Key: 4351563
• MDR Text Key: 5144571
• Report Number: 9611102-2014-00014
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8792.636
• Device Catalogue Number: 8792.636
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other