Description of Event or Problem · 1
WIEST GMBH OF BERLIN, GERMANY MANUFACTURED THE OLYMPUS CORP. SURGICAL CO2 INSUFFLATOR. ANOTHER UNIT WAS ALSO IN USE ON THIS PATIENT - BOTH UNITS HAVE BEEN SENT OUT FOR EVALUATION BY COUNSEL. ABOVE DESCRIBED DEVICES WERE USED IN LAPAROSCOPIC PROCEDURE. ALARM SOUNDED ON C02 INSUFFLATOR (INDICATING PRESSURE PROBLEM) DURING OR SHORTLY AFTER ARGON BEAM COAGULATOR USAGE. PATIENTS VITAL SIGNS DETERIORATED AND EVENTUALLY PATIENT ARRESTED. PATIENT DID NOT RESPOND TO RESUSCITATIVE PROCEDUREDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.