WAVE SIDE GRASPER FORCEPS

Description of Event or Problem

FACILITY REPORT: LAP HERNIA REPAIR PERFORMED BY SURGEON ON (B)(6) 2011. DURING THE CASE AN INSTRUMENT CALLED A GRASPER WAS USED. A PORTION OF THE INSTRUMENT BROKE OFF DURING THE PROCEDURE. THE SURGEON ATTEMPTED TO LOCATE THE BROKEN GRASPER PIECE ON THE MONITOR. FLUORO WAS BROUGHT IN AND THE GRASPER PIECE WAS IDENTIFIED BUT IT COULD NOT BE REMOVED LAPAROSCOPICALLY. SMALL INCISION WAS MADE AND THE PIECE OF THE GRASPER WAS RECOVERED. E-MAIL RECEIVED FROM THE FACILITY ON (B)(4) 2011 REPORTED THAT "THE PT IS DOING WELL."

Additional Manufacturer Narrative

DEVICE WAS RECEIVED AND EVALUATED INTERNALLY BY RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) AND MANUFACTURING SITE (B)(4). BROKEN JAW WAS CONFIRMED. TOP JAW IS STILL INTACT BUT IS BENT SIDEWAYS INDICATING THE INSTRUMENT WAS MISUSED. DISTRIBUTION DATE: 12/2008. FACILITY HAS PURCHASED 126 WAVE SIDE GRASPERS YTD, 21 DEVICES WERE LABELED WITH LOT # 1M08. (B)(4). SERVICE RECORDS WERE REVIEWED, FACILITY HAS NOT USED RWMIC AS THEIR SERVICE PROVIDER FOR THIS DEVICE SINCE DISTRIBUTION ((B)(4), ALL LOT NUMBERS). AN E-MAIL RECEIVED FROM THIS FACILITY CONFIRMED THAT THEY ARE USING 3RD PARTY SERVICES AFTER WARRANTY PERIOD. (B)(4). RWMIC HAS TWO MDR'S ON FILE THAT WERE A RESULT OF BREAKAGE DURING A LAP HERNIA PROCEDURE (1418479-2011-00021 AND 1418479-2011-00025). LOT NUMBER AND FACILITY ARE NOT THE SAME. BASED ON INFO, LIKELY ROOT CAUSE IS MISUSE (NOT USED AS INTENDED), EXCESSIVE FORCE (I.E. PULLING OR TWISTING SIDEWAYS), AND IMPROPER MAINTENANCE (I.E. NONE OR UN-AUTHORIZED REPAIR).