Description of Event or Problem · 1
THE DISTRIBUTOR BECAME AWARE ON OCTOBER 18, 1993 OF AN INCIDENT INVOLVING A RADIAL JAW BIOPSY FORCEP. THE ORIGINAL PROCEDURE, A SMALL BOWL BIOPSY, WAS COMPLETED WIWTHOUT INCIDENT. ONE OR TWO DAYS FOLLOWING THE PROCEDURE THE PATIENT RETURNED TO THE HOSPITAL AND WAS DIAGNOSED WITH A PROFUSE UPPER GI BLEED REQUIRING BLOOD TRANSFUSIONS. A VISIBLE ACTIVE BLEED WAS NOTED AT THE BIOPSY SITE. THE AREA WAS SUCCESSFULLY SCLEROSED AND CAUTERIZED. NO MALFUNCTION OF THE PRODUCT WAS DETERMINED. THE PHYSICIAN STATED THE PRODUCT FUNCTIONED APPROPRIATELY DURING USE.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 DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.