BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUMCISION CLAMP, SIZE: 1.3CM

    MDR report key: 4717981 · Received April 21, 2015

    Report

    Report Number
    2320762-2015-00004
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    October 9, 2013
    Report Date
    April 17, 2015
    Manufacturer
    G.A. SURGICAL (PVT) LTD.
    Product Code
    HFX
    PMA / PMN Number
    K043533
    Removal / Correction Number
    300040625-01/27/2014-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: WHEN THE REPORT WAS RECEIVED THE QC COMPLAINT SPECIALIST REVIEWED THE WORK ORDER TO OBTAIN THE RAW MATERIAL RAW MATERIAL LOT NUMBER IN REFERENCE TO THE REPORT. RAW MATERIAL (B)(4) LOT NUMBER PO 1160146. THE QC COMPLAINT SPECIALIST REVIEWED THE LOT ORDER INQUIRY TO IDENTIFY THE FINISHED GOOD LOT NUMBERS THAT INCLUDED THE RAW MATERIAL AND RAW MATERIAL LOT NUMBER. SEE BELOW. FINISHED GOOD LOT NUMBER QUANTITY PRODUCED: 32-1622 33423747 (B)(4) CASES; 32-1622 33444071 (B)(4) CASES; 32-1622 33347799 (B)(4) CASES. A REQUEST HAS BEEN SENT TO EACH OF THE FACILITIES THAT UTILIZE THE RAW MATERIAL TO PLACE THE IDENTIFIED LOT NUMBER UNDER QUARANTINE. IN ADDITION, A REQUEST WAS SUBMITTED TO DDC TO REQUEST EACH OF THE FINISHED GOODS IDENTIFIED BE PLACED UNDER QUARANTINE DUE TO CUSTOMER COMPLAINTS RECEIVED IN REFERENCE TO THE ISSUES WITH THE PRODUCT. (B)(4) HAS BEEN ISSUED TO THE VENDOR. THE VENDOR RESPONDED WITHIN A LETTER ON THEIR COMPANY LETTER HEAD. WITHIN THE RESPONSES IT WAS INDICATED THE QUALITY ISSUES ARE DUE TO THE ISSUES THAT OCCURRED WAS DUE TO THE PRODUCT NOT BEING PROPERLY INSPECTED. IN ADDITION, THE VENDOR HAS RESPONDED STATING THAT A PLASTIC WASHER IS NOT PART OF THEIR PRODUCTS DESIGN. UPDATED: A FURTHER REVIEW OF THE COMPLAINT HAS IDENTIFIED THAT THE COMPLAINT WILL BE REQUIRED FOR UPDATES. DEROYAL REGULATORY DEPARTMENT HAS BEEN NOTIFIED OF THE RE-OPENING OF THE REPORT. AFTER THE COMPLETION OF TH E INITIAL INVESTIGATION THE FINISHED GOOD AND LOT NUMBER IDENTIFIED WAS INCLUDED WITHIN A DEROYAL RECALL THAT WAS LIMITED TO THE FINISHED GOODS THAT CONTAINED THE GALAXY INSTRUMENT SUPPLIED CIRCUMCISION CLAMPS. THE GALAXY CIRCUMCISION CLAMPS WERE IDENTIFIED AS BEING A ONE-TIME PURCHASE BY DEROYAL SUPPLY CHAIN DUE TO A BACKORDER SITUATION WITH OUR PRIMARY VENDOR. IT WENT UNNOTICED THAT THE WASHER WAS NOT PART OF THE DESIGN. TO ADDRESS THE ISSUE INTERNALLY DEROYAL INITIATED CAPA (B)(4). THIS ACTION POINT HAS BEEN COMPLETED AND VERIFIED EFFECTIVE.

    Description of Event or Problem · 1

    PRODUCT HAS A DESIGN FLOW COMPARED TO THE OLDER DESIGN IN LOT #3348118, IT APPEARS IT DOES NOT CLAMP WELL ENOUGH TO CREATE SEAL WHERE FORESKIN IS PINCHED. THE CLAMP NEEDS TO BE SEALED TIGHT FOR THE PURPOSE OF CLAMPING THE VESSEL TO PREVENT BLOOD FLOW. IF NOT A TIGHT SEAL THAN THERE WILL BE EXCESSIVE BLEEDING AND THEY WILL NEED TO STITCH THE WOUNDS WHICH IS NOT REQUIRED. THIS EXTRA STEP CAN CAUSE LONGER HEALING TIME, INCREASED STAY AT THE HOSPITAL, AND DISTRESS TO THE PATENTS. THERE ALSO APPEARS TO BE A PLASTIC WASHER MISSING FROM THE CLAMP THAT HELP WITH THE COMPRESSION AND EASE OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261779 CIRCUMCISION CLAMP, SIZE: 1.3CM CLAMP, CIRCUMCISION HFX G.A. SURGICAL (PVT) LTD. 33347799

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention