FORCEPS, INSERT, PLATE SHAPED

Additional Manufacturer Narrative

AN INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACILITY ON (B)(6) 2013. SEGMENT CONNECTING PULLROD WITH JAW WAS BROKEN. IN ADDITION, BOTTOM HALF OF WALL SURROUNDING THE PIN WAS MISSING. TEETH SHOW SIGNS OF HEAVY USE. WHEN FORCEPS ASSEMBLED WITH SHEATH, ALL PARTS ARE CONTAINED. DEVICE HISTORY: MANUFACTURED 05/2011, SOLD ON (B)(4) 2012; NO RECORD OF ANY REPAIRS OR ROUTINE MAINTENANCE OF DEVICE. NO SIMILAR COMPLAINTS IN THE LAST FIVE YEARS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. I.E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFO, WE WILL PROVIDE FDA WITH FOLLOW-UP INFO.

Description of Event or Problem

SALES REPRESENTATIVE REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) A PATIENT RETURNED TO HOSPITAL AFTER A BARIATRIC PROCEDURE AND IS CURRENTLY IN FOR A PROLONGED STAY. THERE WERE MANY INSTRUMENTS USED DURING THE PROCEDURE. TWO HAVE BEN IDENTIFIED AS BEING MANUFACTURED BY RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (B)(4). FORCEPS INSERT (8393.182) (B)(4). INSULATED SHEATH (8393.913) (B)(4).