BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 8489594 · Received April 5, 2019

    Report

    Report Number
    2027111-2019-00409
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    February 6, 2019
    Report Date
    April 5, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE TO BE PERFORMED AND THE COMPLAINANT¿S EXPERIENCE COULD NOT BE REPLICATED OR CONFIRMED. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAP CHOLECYSTECTOMY. CER 1 OF 3: (B)(4) - WILL ADDRESS EVENT FROM (B)(6) 2019. CER 2 OF 3: (B)(4) - WILL ADDRESS EVENT FROM (B)(6) 2019. CER 3 OF 3: (B)(4) - WILL ADDRESS EVENT FROM (B)(6) 2019. LIMITED INFORMATION AVAILABLE AT THIS TIME. MISSING METAL SUPPORTS, ONLY HAS THE STRING ATTACHED. REPLACED WITH ANOTHER LOT THAT THEY HAD IN THEIR STOCK. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM ASSISTANT DIRECTOR MATERIALS MANAGEMENT: EVENT DATES WERE (B)(6) 2019 11:30 AM, (B)(6) 2019 12:30 ISH, (B)(6) 2019 10:00. THE INCIDENT WAS DETECTED DURING SURGERY. THE PROCEDURES WERE LAP CHOLECYSTECTOMY X 3. OUR GENERAL SURGEON WAS DOING THESE PROCEDURES, DURING THESE PROCEDURES IT TOOK AN EXTRA 30 MINUTES AS THE DOCTOR WAS NOT ABLE TO KEEP THE BAG OPEN. PATIENT STATUS IS STABLE. THERE WAS NO PATIENT INJURY. THERE ARE NO PHOTOS AVAILABLE. SO FAR WE HAVE TWO UNITS FROM DIFFERENT LOTS AVAILABLE LOT #133677 AND LOT #1336128, SO FAR TWO WE HAVE TO KEEP SOME IN STOCK AS WE HAVE SEVERAL SURGERIES THIS WEEK THAT REQUIRE THIS PRODUCT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2019 FROM ASSISTANT DIRECTOR MATERIALS MANAGEMENT: THE LOT NUMBER PREVIOUSLY REPORTED AS 133677 HAS BEEN CONFIRMED BY THE CUSTOMER AS LOT #1333677. BOTH OF THE LOTS LISTED HAVE THE SAME PART OF THE BAG MISSING. UNABLE TO CONFIRM IF THERE HAVE BEEN ANY UNITS FROM EITHER BOX THAT HAVE BEEN USED AND DID NOT HAVE THE MISSING METAL SUPPORTS, BUT I DO BELIEVE THEY SAID IT WAS BOTH. ONLY HAVE STERILE UNITS TO RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(4) 2019 FROM APPLIED MEDICAL ACCOUNT MGR: I WAS SUPPOSED TO MEET WITH THE ACCOUNT TODAY BUT WITH THE SNOW STORM (B)(6) GOT, I WAS NOT ABLE TO GO OUT. I SPOKE WITH [SURGERY MANAGER] EARLIER THIS WEEK, AND SHE MENTIONED THAT SHE THINKS IT WAS THE METAL PRONGS THAT OPEN THE BAG WHEN IT IS DEPLOYED. SHE DOESN¿T THINK THEY WERE THERE WHEN THE BAG WAS DEPLOYED. WHEN I SPEAK WITH HER AGAIN ON (B)(6), I WILL BE SURE TO FOLLOW UP! ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(4) 2019 APPLIED MEDICAL ACCOUNT MGR: I JUST VISITED THE ACCOUNT AND SPOKE WITH BOTH THE SURGEON AND THE STAFF. THEY SHOWED ME THE BAGS AND I GOT A COUPLE DIFFERENT LOT NUMBERS. THE BAG WAS DEPLOYED, HOWEVER THE PRONGS WERE NOT ON THE BAG. SO WHEN THE BAG WAS DEPLOYED IT DID NOT OPEN. RATHER THE PRONGS JUST PUSHED THE BAG OUT AND THEN THE PRONGS FOLLOWED BEHIND THE BAG, EVENTUALLY EXITING THE INTRODUCER AND THE PRONGS OPENING WIDE AS THEY NORMALLY WOULD, EXCEPT WITHOUT THE BAG ATTACHED. THEY ASKED IF IT WAS MECHANICAL OR USER ERROR. I TOLD THEM FROM THE LOOKS OF IT, IT APPEARS TO BE MECHANICAL, BUT I WILL FOLLOW UP WITH APPLIED AND WE WILL GO FROM THERE. THE SURGEON DEMONSTRATED HOW HE DEPLOYS THE BAG, AND HIS TECHNIQUE IS THE CORRECT TECHNIQUE FOR OUR BAGS. PATIENT STATUS: STABLE. TYPE OF INTERVENTION: USED ANOTHER LOT IN STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280369 CD001, 10MM RETRIEVAL SYSTEM, 10/BX GCJ GCJ APPLIED MEDICAL RESOURCES CD001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1