BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANG&GO HT BASIC

    MDR report key: 6566198 · Received May 15, 2017

    Report

    Report Number
    3003793891-2017-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    April 3, 2017
    Report Date
    June 1, 2017
    Manufacturer
    RAND S.R.L.
    Product Code
    LGZ
    PMA / PMN Number
    K120026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (PLEASE NOTICE THAT THIS INCIDENT WAS REPORTED ON MAY 14TH VIA (B)(6) WITH REPORT # 3009763610-2017-00001, BUT THEN I REALIZED THAT I INPUT THE WRONG FEI NUMBER, SO I ASKED CDRH EMDR TO DELETE IT. I'M NOW REPLACING IT WITH THE CORRECT REPORT. DELAY OF THIS REPORT IS DUE TO THIS REASON). THE PROBLEM WAS REPORTED BY A (B)(6) CUSTOMER ON A MEDICAL DEVICE, WHICH IS TECHNICALLY SIMILAR TO CODE R9900090, CLEARED UNDER 510(K) # K120026, AND THUS COULD POTENTIALLY AFFECT ALSO THIS PRODUCT. (B)(4) UNITS OF CODE R9900090 WERE DELIVERED TO OUR IMPORTER (B)(4) IN A SHIPPING KIT, CODE R9900120 (THE UDI REFERS TO THIS KIT). ALL (B)(4) UNITS ARE STILL IN (B)(4) WAREHOUSE, NONE OF THEM HAVE BEEN DISTRIBUTED TO US CUSTOMERS. THE PROBLEM REGARDS THE FEMALE CONNECTION CAP ON THE TABLE PACK LINE OF THE HANG&GO DISPOSABLE DEVICE. OCCASIONALLY, THE CAP ON THE FEMALE QUICK CONNECTOR OF THE TABLE PACK LINE IS A LITTLE LOOSE AND IT MIGHT ACCIDENTALLY FALL OFF. IN CASE THE TABLE PACK LINES ARE IMPROPERLY UNPACKAGED AND HANDLED CLOSE TO THE PATIENT LAPAROTOMY, THERE IS A POTENTIAL RISK THAT THE CAP MIGHT FALL INTO IT. RAND HAS ESTIMATED THAT THE LIKELIHOOD OF THIS OCCURRENCE IS IMPROBABLE. SUCH EVENT HAS NEVER BEEN REPORTED TO RAND. THE GOOD PRACTICE IS TO UNPACK AND PREPARE THE TABLE PACK LINES ON THE BACK TABLE ASIDE THE PATIENT, UNDER THE RESPONSIBILITY AND SUPERVISION OF THE SCRUB NURSE. THE CUSTOMER'S COMPLAINT HAS TAKEN TO OUR ATTENTION THAT THIS HANDLING IS SOMETIMES DONE ON THE OPERATING TABLE, BUT NOT REALLY ON THE SURGICAL WOUND, SO EVEN IN THIS CASE, THE PROBABILITY THAT THE CAP FALLS RIGHT INTO THE SURGICAL WOUND IS LOW. NOT LEAST, TO THE BEST OF OUR KNOWLEDGE OUR US CUSTOMERS DO NOT OPERATE WITH OPEN-ABDOMEN TECHNIQUE, BUT CLOSE-ABDOMEN TECHNIQUE, WHICH MAKES THE HAZARD IMPOSSIBLE TO OCCUR. THIS SAID, WE BELIEVE THAT NO RISK IS POTENTIALLY ASSOCIATED WITH THE USE OF THIS PRODUCT IN THE USA, BUT SINCE ALL INVOLVED UNITS ARE STILL AT OUR IMPORTER (B)(4) WAREHOUSE, WE DECIDED TO WITHDRAW AND REWORK THEM ANYWAY TO REPLACE THE DEFECTIVE CAPS ON THE TABLE PACK LINES WITH THE PREVIOUS CAPS (WHICH WERE REPLACED ONLY FOR PROVISIONING ISSUES) THAT HAVE BEEN IN USE FOR YEARS AND THAT ARE TIGHTER, SO THEY DO NOT FALL OFF. AS A FURTHER MEASURE, AN ADDITIONAL PRECAUTION FOR THE USER WILL BE INCLUDED IN THE INSTRUCTIONS FOR USE: "NEVER UNPACK OR PREPARE THE TABLE PACK LINES CLOSE TO THE PATIENT'S SURGICAL WOUND. DETACHABLE PARTS NOT WELL SECURED COULD FALL INTO THE PATIENT'S CAVITY WITHOUT BEING NOTICED". THE UNITS IN (B)(4) HAVE BEEN PUT ON HOLD. THEY WILL BE RETURNED TO RAND BY END OF THIS WEEK (FRIDAY 19TH).

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT WE STATED THAT KITS IN RAND USA WAREHOUSE WERE PUT ON HOLD AND WOULD HAVE BEEN RETURNED TO RAND FOR RE-WORKING. THEY ACTUALLY ARRIVED IN RAND (B)(4) WAREHOUSE ON (B)(6). THEY ARE NOW UNDER REWORKING IN ORDER TO REPLACE THE DEFECTIVE CAPS WITH THE PREVIOUS ONES, WHICH DO NOT SHOW THE SAME DEFECT. INSTRUCTIONS FOR USE OF THE PRODUCT HAVE BEEN ACTUALLY REVISED AND RELEASED WITH THE INCLUSION OF THE ADDITIONAL PRECAUTION, AS STATED IN THE INITIAL REPORT. THE REMEDIAL ACTION IS CONSIDERED CLOSED FOR USA.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) HOSPITAL REPORTED TO RAND THAT THEY NOTICED THAT THE FEMALE CONNECTION CAP ON THE PRODUCT WAS LOOSE AND HAS FELL OFF DURING SETUP. THEY REPORTED A CONCERN THAT THIS MAY LEAD TO AN INCIDENT WITH THE INNER PIECE FALLING INTO THE PATIENT ABDOMEN WITHOUT KNOWING. HOWEVER, THE PRODUCT WAS USED BY THE CUSTOMER WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349219 HANG&GO HT BASIC HANG&GO HT BASIC LGZ RAND S.R.L. R9900090 F170052

    Patients

    Seq Age Sex Outcome Treatment
    1