Description of Event or Problem · 1
THIS DISTRIBUTOR BECAME AWARE ON 10/7/93 OF A SITUATION INVOLVING DETACHMENT OF A SINGLE CUP OF THE BIOSPY FORCEPS IN THE PATIENT'S UPPER GI TRACT. UPON REMOVAL OF THE FORCEPS, ATTEMPTING TO OBTAIN A SECOND SPECIMEN IN THE UPPER GI TRACT, IT WAS NOTED A CUP HAD DETACHED. FLUOROSCOPY REVEALED THE DETACHED CUP REMAINED IN THE PATIENT'S MUCOSA. ANOTHER FORCEP WAS USED TO RETREIVED THE DETACHED CUP WITHOUT INCIDENT ANAD THE PROCEDURE WAS COMPLETED WIWTH THIS SECOND UNIT WITHOUT COMPLICATIONS. THE PATIENT EXPERIENCED NO SEQUELAE AS A RESULT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.