FDA Adverse Event Malfunction Summary report: N

RONGEUR

MDR report key: 4351563 · Received December 11, 2014

Report

Report Number: 9611102-2014-00014
Event Type: Malfunction
Date Received: December 11, 2014
Date of Event: August 1, 2014
Report Date: December 11, 2014
Manufacturer: RICHARD WOLF GMBH
Product Code: HTX
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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.

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
806913	RONGEUR	RONGEUR	HTX	RICHARD WOLF GMBH	8792.636

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other