Description of Event or Problem · 1
ON 4/21/93 PATIENT UNDERWENT A LAPROSCOPIC HIATAL HERNIORRAPHY AND NISSEN FUNDOPLICATION. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR EMERGENCY SURGERY WITH A NOTED DISCHARGE DIAGNOSIS OF BILATERAL PLEURAL EFFUSION, MEDIASTINITIS AND SHOCK PROBABLY DUE TO GASTIC JUICE LEAKAGE. PATIENT EXPIRED ON 4/27/983. AFTER INITIAL INVESTIGATION HAD BEEN CONDUCTED AND NOT UNTIL 5/7/93 WAS IT NOTED THAT THE SURGEON HAD DESCRIBED DEFECTIVE SURTURE DEVICES IN HIS OPERATIVE NOTE. UPON FURTHER INVESTIGATION WITH THE SURGEON HE NOTED THAT HE HAD USED THREE SURGI-WIPS AND ALL THREE SURGI-WIPS DID NOT WORK PROPERLY. HE STATED THAT HE PLACED THE SUTURE WITH THE NEEDLE THROUGH THE TISSUE AND BROUGHT THE SUTURE AND NEEDLE OUT THROUGH THE SURGIPORT. HE THEN TIED A FISHERMAN'S KNOT EXTRACORPOREAL AND ATTEMPTED TO SLIDE THE KNOT THROUGH THE METAL SHAFT OF THE SURGI-WIP, THE SUTURE BROKE BELOW THE WHITE PLASTIC KNOT PUSHER. ONE TIME THE SUTURE BROKE AT THE FISHERMAN'S KNOT. THE SECOND BREAK WAS FROM THE WHITE PLASTIC TIP ATTACHMENT AT THE TOP OF THE METAL SHAFT OF THE SURGI-WIP. THE THRID TIME THE WHITE PLASTIC KNOT PUSHER WOULD NOT SLIDE THROUGH THE METAL SHAFT OF THE SURGI-WIP. THE DR. USED FORCEPS TO PUSHE THE KNOT THROUGHDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.