Description of Event or Problem · 1
THIS (B)(6) HEALTHY NEWBORN MALE WAS TO UNDERGO A ROUTINE CIRCUMCISION PERFORMED BY AN EXPERIENCED OBSTETRICIAN. DURING THE PLACEMENT OF THE BELL AND CLAMP, THE PHYSICIAN WAS NOT SATISFIED WITH THE COMPONENTS OF THE FIRST CIRCUMCISION TRAY COMPONENTS, SO REQUESTED ANOTHER TRAY BE OPENED. SHE INTERCHANGED THE CLAMP WHILE LEAVING THE BELL IN PLACE, AND, THEREFORE, DID NOT CHECK IF THE NEW COMPONENTS FIT TOGETHER PROPERLY. DURING HER FIRST CUT, THE INSTRUMENT SLIPPED CAUSING A DEGLOVING INJURY OF THE SHAFT OF THE PENIS. THE STANDARD PRACTICE IN THIS FACILITY IS THE USE OF GOMCO SURGICAL INSTRUMENTS ASSEMBLED IN A TRAY (CIRCUMCISION) THAT IS RETURNED AND RE-STERILIZED IN THE CENTRAL PROCESSING DEPARTMENT ON CAMPUS. THE EXCEPTION TO THIS RULE IS THE USE OF THE PLASTIC BELL DEVICE USED BY THE PEDIATRIC SURGEONS IN THE NICU AND PEDIATRICS. HOWEVER, SOME DISPOSABLE SETS WERE LEFT IN OB TO BE USED ON A TRIAL BASIS AS INSTRUMENT TRAYS WERE ALWAYS READILY AVAILABLE FOR USE. DESPITE THESE BEING IDENTIFIED AS "DISPOSABLE," THE APPEARANCE OF COMPONENTS OF THE KIT LOOKED VERY SIMILAR TO THE REUSABLE ONES THAT ARE IN USE ON A ROUTINE BASIS. WITH CAREFUL INSPECTION, IT WAS QUESTIONED IF THESE DISPOSABLE ITEMS WERE RETURNED TO CENTRAL PROCESSING AS A RESULT WAS INTER-MIXED WITH THE GOMCO PRODUCT. AFTER CAREFUL INSPECTION OF THE INSTRUMENTS, IT WAS NOTED THAT THE BELLS DIFFERED IN LENGTH BY APPROXIMATELY 3 MM. THIS COULD LEAD TO A CLAMP THAT IS NOT PROPER AND SAFE FOR USE IN THE PROCEDURE.THE DISPOSABLE KITS WERE TAKEN OFF THE SHELF IMMEDIATELY. THOSE PHYSICIANS CREDENTIALED IN CIRCUMCISION PROCEDURE WERE NOTIFIED THAT THE GOMCO COMPONENTS ARE NOT INTERCHANGEABLE. THE PLASTIC BELL DEVICE WILL CONTINUE TO BE SUPPORTED BY THE PEDIATRIC SURGEONS.