Description of Event or Problem · 1
TELEPHONE CALL REC'D FROM THE RPTR INDICATING THE PT UNDERWENT AN ABDOMINAL HYSTERECTOMY. THE BROKEN TIP WAS NOT NOTICED UNTIL THE PT'S ABDOMEN HAD BEEN CLOSED. TWO RETAINED PIECES WERE DETECTED BY X-RAY AND MRI. THE USER FACILITY HAS REFUSED TO RELEASE THE INSTRUMENT FOR EVAL. JARIT REP WILL BE ON-SITE AT THE USER FACILITY TO EXAMINE THE NEEDLE HOLDER. THE INITIAL CONTACT WITH JARIT REGARDING THIS COMPLAINT WAS PER A TELEPHONE CONVERSATION, WHERE THE HOSP REQUESTED INFO REGARDING THE CARBIDE MATERIAL DUE TO A BROKEN NEEDLE HOLDER WHICH OCCURRED DURING AN OPERATION. THE BROKEN TIP WAS NOT NOTICED UNTIL AFTER THE OPERATION WAS COMPLETED, AND TWO PIECES SUBSEQUENTLY WERE DETECTED BY X-RAY AND MRI. THE VENDOR OF THE CARBIDE INSERTS AND A SURGICAL INSTRUMENT LABORATORY WERE CONTACTED, AND THEY BOTH DID NOT HAVE ANY LITERATURE OR INFO REGARDING THE EFFECT OF TUNGSTEN CARBIDE ON THE HUMAN BODY. THE LAB DID POINT OUT THAT SINCE TUNGSTEN CARBIDE IS NOT USED AS A MATERIAL FOR IMPLANTS, IT WOULD BE ADVISABLE NOT TO LEAVE THE BROKEN PIECES OF THE CARBIDE INSERT IN THE PT'S BODY. AS A FOLLOW UP TO THE COMPLAINT, JARIT'S DISTRIBUTOR, SENT A REP TO EXAMINE THE INSTRUMENT IN QUESTION. THE REP EVAL CONFIRMED THE NEEDLE HOLDER WAS A JARIT INSTRUMENT, AND DETERMINED THE INSERT WAS PREVIOUSLY REPAIRED BY A VENDOR ASSOCIATED WITH THE HOSP. IN THEIR OPINION, THE REPAIR WAS SUB-STANDARD DUE TO EXCESS SOLDER ON THE SIDES AND TO THE REAR OF THE INSERT.