BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50L ABDOMINAL INSUFFLATOR

    MDR report key: 6090268 · Received November 9, 2016

    Report

    Report Number
    1017294-2016-00121
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 10, 2016
    Report Date
    January 9, 2017
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    HIF
    PMA / PMN Number
    K022052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED IS AWARE OF 11 REPORTS (OVER 3 YEARS) WHERE USERS CLAIM TO HAVE FAILED TO HEAR THE LOW-GAS ALARM AND/OR A UNIT HAS RUN OUT OF GAS. DURING THIS SAME TIME FRAME, APPROXIMATELY 80 UNITS HAVE BEEN SUPPLIED TO USER FACILITIES IN (B)(6) AND ARE IN FREQUENT DAILY USE. IT IS NOTED THAT (B)(6) CO2 CYLINDERS ARE SMALL AND REQUIRE FREQUENT MONITORING AND CHANGE OVER. (B)(6) IS THE ONLY COUNTRY WHERE THESE SIMILAR EVENTS HAVE BEEN REPORTED. THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR SIGNIFICANT SURGICAL DELAYS. CONMED HAS SOUGHT AN INTERIM OPINION FROM A HEALTHCARE PROFESSIONAL, WITH FINDINGS INDICATING AN EXTREMELY LOW PROBABILITY OF INTERNAL ORGAN PERFORATION RESULTING FROM A LOSS IN ABDOMINAL DISTENSION. A LOSS OF PRESSURE WOULD BE IMMEDIATELY AND VISUALLY OBVIOUS TO MEDICAL STAFF WHO WOULD HAVE A REASONABLE AMOUNT OF TIME TO REMOVE SURGICAL INSTRUMENTS IF NECESSARY FROM THE ABDOMINAL CAVITY. THE MANUFACTURER IS REVIEWING THEIR GLOBAL COMPLAINTS HISTORY FOR ANY SIMILAR REPORTS AND IS FINALIZING THEIR REVIEW OF THE ASSOCIATE CLINICAL SERVICES COORDINATOR'S FEEDBACK OPINION. TO DATE, THERE HAVE BEEN NO REPORTS OF ANY PATIENT LONG TERM EFFECTS RESULTING FROM THIS TYPE OF INCIDENT. A FOLLOW-UP REPORT WILL BE FILED ONCE THE MANUFACTURER'S EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER (B)(4) HAS CONDUCTED A REVIEW OF GLOBAL COMPLAINTS FOR SIMILAR REPORTS. A TOTAL OF 19 COMPLAINTS WERE RAISED DURING 2015 AND 2016 FROM THE SAME 'FAMILY' OF 50-LITER ABDOMINAL INSUFFLATION UNITS. THIS INCLUDES CONMED GS2000, SMITH & NEPHEW 500, NOVADAQ 50L AND NEBULAE I. ONLY ONE COMPLAINT HAS BEEN RECEIVED FOR A NON-GS2000 INSUFFLATOR. (B)(4) UNITS FROM THIS DEVICE FAMILY HAVE BEEN SUPPLIED WORLDWIDE. (B)(4) SUPPORTS THE HEALTH HAZARD EVALUATION CONDUCTED BY CONMED CORPORATION USA WITH FINDINGS INDICATING AN EXTREMELY LOW PROBABILITY OF INTERNAL ORGAN PERFORATION RESULTING FROM A LOSS IN ABDOMINAL DISTENSION. FROM AN INSTALLED BASE OF APPROXIMATELY 80-GS2000 UNITS IN (B)(6) AND 994 50-LITER ABDOMINAL INSUFFLATORS WORLDWIDE (TOTAL FAMILY) THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR SIGNIFICANT SURGICAL DELAYS. (B)(4) HAS DECIDED TO IMPLEMENT A SOFTWARE UPDATE TO INCREASE BOTH THE ALARM VOLUME LEVEL AND FREQUENCY OF OCCURRENCE OF THE LOW-GAS ALERT. SOFTWARE REQUIREMENTS ARE CURRENTLY BEING ASSESSED. INVESTIGATION REMAINS IN PROCESS, A SECOND FOLLOW-UP REPORT WILL BE FILED ON OR BEFORE 08-JAN-2017.

    Additional Manufacturer Narrative · 1

    THE INSUFFLATOR WAS NOT RETURNED TO CONMED OR THE MANUFACTURER NORTHGATE TECHNOLOGIES INC. FOR AN EVALUATION TO BE PERFORMED. THE REPORTED ISSUES WERE NOT ABLE TO BE CONFIRMED. THE SERIAL NUMBER OF THE UNIT THAT IS THE SUBJECT OF THIS COMPLAINT WAS NOT PROVIDED. THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY SHOWS A TOTAL OF 8 COMPLAINT REPORTS FOR SIMILAR ISSUES. THERE HAVE BEEN NO ADVERSE EVENTS REPORTED THAT ARE RELATED TO THIS FAILURE MODE. CONMED WILL CONTINUE TO MONITOR THIS DEVICE VIA RETURNS AND THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    AN ASSOCIATE CLINICAL SERVICES COORDINATOR AT THE USER FACILITY REPORTED THAT (IN REFERENCE TO THEIR GS2000 50L ABDOMINAL INSUFFLATOR) "NO INDICATION IS GIVEN WHEN CO2 CYLINDERS ARE EMPTY, THE INDICATOR SCREEN INDICATES THAT THE CYLINDERS ARE STILL FULL BUT PRESSURE CANNOT BE MAINTAINED OR ON OCCASION A RESTRICTION TO FLOW IS SHOWN". SHE ALSO REPORTED "WE FIND THAT THIS IS NOT ACCEPTABLE AND A DANGER TO OUR PATIENTS, CAUSING AT LEAST UNNECESSARY DELAYS, UNSAFE ABDOMINAL PORT INSERTION OR AT A WORST PERFORATION OF ABDOMINAL ORGANS OR CANCELLATION OF PROCEDURES". WHILE THERE WAS NO ADVERSE EVENT AND AN INDICATION IS GIVEN WHEN CO2 CYLINDERS ARE LOW / EMPTY, THIS REPORT IS BEING FILED SOLELY ON THE BASIS OF THE ASSOCIATE CLINICAL SERVICES COORDINATOR'S FEEDBACK. THIS FACILITY HAS THREE (3) GS2000 UNITS THAT WERE PURCHASED DEC-2015, APR-2016 AND MAY-2016 HOWEVER THE SPECIFIC SERIAL NUMBER UNIT WHICH IS THE SUBJECT OF THIS REPORT HAS NOT BEEN IDENTIFIED. THE SERIAL NUMBERS AT THIS FACILITY ARE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742450 50L ABDOMINAL INSUFFLATOR INSUFFLATOR, LAPAROSCOPIC HIF NORTHGATE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other