BEUDAMED
    FDA Adverse Event Death Summary report: N

    CO2EFFICIENT ENDOSCOPIC INSUFFLATOR

    MDR report key: 3131001 · Received May 21, 2013

    Report

    Report Number
    2411512-2013-00011
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BRACCO UNK LTD
    Product Code
    FCX
    PMA / PMN Number
    K053008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE BRACCO CO2-EFFICIENT INSUFFLATOR THAT WAS USED IN THIS COMBINATION, THERE ARE TWO PROTECTIVE MEASURES IN PLACE THAT SHALL PREVENT EXCESSIVE PRESSURE: AN ELECTRONICALLY CONTROLLED VALVE (THRESHOLD 375 MM HG) AND A MECHANICAL VALVE (THRESHOLD 400 MM HG). THE INSTRUCTIONS FOR USE (IFU) OF THIS DEVICE PROVIDES DEDICATED WARNINGS. ALSO FOR THE PENTAX CO2-VALVE IT IS NOT YET CLEAR WHETHER IT MAY HAVE CONTRIBUTED TO THE PERFORATION OR NOT. THE IFU FOR THE COLONOSCOPE PROVIDE DEDICATED WARNINGS REGARDING THE RISK OF OVERINSUFFLATION AND PNEUMATIC PERFORATION. FURTHERMORE CLOSE MONITORING OF THE PT IS MANDATORY IN ORDER TO AVOID OVERINSUFFLATION OR PNEUMATIC PERFORATION (IFU, PAGE 24). THE IFU OF THE CO2 VALVE PROVIDES DETAILED INFO CONCERNING THE PREPARATION AND THE INSPECTION PRIOR TO USE. BASED ON THE IFU AND THE PROTECTIVE MEASURES WE BELIEVE A POTENTIAL OVERINSUFFLATION SHOULD HAVE BEEN DETECTED AT A VERY EARLY STAGE AND, UNDER THE PROVISION THE PROTECTIVE MEASURES WERE WORKING PROPERLY, AN OVERINSUFFLATION SHOULD HAVE BEEN PREVENTED AT ALL. WE CANNOT CONCLUDE THAT AN OVERINSUFFLATION LEAD TO THE PERFORATION. COMPANY COMMENTS: A (B)(6) PT WITH A HISTORY OF PREVIOUS SURGERY ON THE COLON EXPERIENCED COLON PERFORATION DURING A COLONOSCOPY USING E-Z-EM CO2-EFFICIENT ENDOSCOPIC INSUFFLATOR, FLEXIBLE VIDEO COLOSCOPE EC-3890FI2 (MFR UNK, SER NUMBER (B)(4)) AND A GAS/WATER FEEDING VALVE (PENTAX, OF-B194). AFTER IMMEDIATE COLON SURGERY, THE PT STABILIZED INITIALLY, BECAME CRITICAL 4 DAYS POSTOPERATIVELY, THEN DIED 3 DAYS AFTER HER WORSENING CLINICAL STATUS. FOR THE BRACCO CO2-EFFICIENT INSUFFLATOR THAT WAS USED IN THIS COMBINATION, THERE ARE TWO PROTECTIVE MEASURES IN PLACE THAT SHALL PREVENT EXCESSIVE PRESSURE. ALTHOUGH A MALFUNCTION OF THE USED CO2 VALVE WAS OBSERVED AFTER THE PROCEDURE, IT WAS NOT CONFIRMED IF AN OVER INSUFFLATION HAD OCCURRED. CONFOUNDING FACTORS FOR THE EVENT WERE PT'S ADVANCED AGE AS WELL AS THE PREVIOUS COLON SURGERIES. FURTHER INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    CAUSE(S) OF DEATH: COLON PERFORATION. NARRATIVE: CASE REC'D FROM A GASTROENTEROLOGIST VIA (B)(6) THROUGH (B)(4) ON (B)(6) 2013 AND FORWARDED TO (B)(4) ON THE SAME DAY. AN (B)(6) FEMALE PT WITH MEDICAL HISTORY OF SURGICAL INTERVENTIONS AT THE COLON PRIOR TO THIS COLOSCOPY UNDERWENT A COLONOSCOPY WITH E-Z-EM CO2-EFFICIENT ENDOSCOPIC INSUFFLATOR ON (B)(6) 2013. FOR THE SAME DIAGNOSTIC PROCEDURE, ALSO FLEXIBLE VIDEO COLOSCOPE EC-3890FI2 (MFR UNK, SER. NUMBER (B)(4)) AND A GAS/WATER FEEDING VALVE (PENTAX, OF-B194) WERE USED. DURING THE COLONOSCOPY PERFORATION OF THE COLON OCCURRED REQUIRING SURGERY WHICH WAS PERFORMED IMMEDIATELY AFTERWARDS. AFTER A RELATIVELY POSITIVE DEVELOPMENT UNTIL (B)(6) 2013, THE PT'S HEALTH STATUS BECAME CRITICAL AND SHE FINALLY DIED ON (B)(6) 2013. AFTER THE COLONOSCOPY THE DEVICES HAD BEEN FLUSHED AS PER NORMAL ROUTINE. DURING THIS AFTER-USE PROCESS IT WAS OBSERVED THAT THE CO2 FLOW THROUGH THE COLONOSCOPE COULD NOT BE STOPPED BY THE CO2 VALVE OF-B194. INSTRUMENTS WERE SECURED AT USER'S FACILITIES AND WERE OUT OF ORDER. AS PER THE INFO PROVIDED BY THE GASTROENTEROLOGIST THE PERFORATION HAS LED TO THE DEATH OF THE PT ON (B)(6) 2013. FURTHER INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225343 CO2EFFICIENT ENDOSCOPIC INSUFFLATOR COLON INSUFFLATOR FCX BRACCO UNK LTD NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death GAS/WATER FEEDING VALVE: EC-3890FI2