BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 6894248 · Received September 26, 2017

    Report

    Report Number
    3005075853-2017-05189
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 1, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/14/2017. D4: BATCH # K92136. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT THE ER420 DEVICE WAS RETURNED WITH A CLIP IN THE JAWS; THE CLIP WAS REMOVED IN ORDER TO INSPECT THE JAWS AND THEY WERE FOUND TO BE NO DAMAGE. IN ADDITION, THE TYVEK WAS RETURNED ALONG WITH THE INSTRUMENT. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE INSTRUMENT WAS CYCLED AND IT FED AND FORMED 13 CONFORMING CLIP; FINALLY, THE DEVICE LOCKED OUT AS INTENDED. THE INSTRUMENT WAS DISASSEMBLED IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS AND THE HANDLE POST WAS NOTED TO BE BROKEN. HOWEVER, IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THIS CONDITION MAY LEAD TO EJECTED CLIP. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE DAMAGE FOUND. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/13/2017. ADDITIONAL INFORMATION: LOT # K4D92T: EXPIRATION DATE 08/31/2017; CERTIFICATION DATE 09/07/2013. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. PATIENT DETAILS: C.B. / FEMALE / 135KG/165CM / 03.12.1980 / LAPAROSCOPIC ROUX-EN-Y, SINGLE ANASTOMOSES BYPASS. SURGERY DELAYED BY TWO MINUTES.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: G6. THIS REPORT IS BEING SUBMITTED PER THE REQUEST OF FDA TO CORRECT SEQUENTIAL NUMBERING FOR THE MDR FOLLOW UP REPORT ORIGINALLY SUBMITTED. THIS IS FOLLOW UP REPORT #1.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS, CLIPS WOULD NOT DISPENSE OUT OF JAWS OF DEVICE ¿ COULD NOT GET CLIPS TO CLOSE ON TISSUE TO FORM. OPENED NEW DEVICE TO RECTIFY. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675799 LIGACLIP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. K4D92T

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female