BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMB FORCEPS (JAWZ)

    MDR report key: 1031585 · Received March 7, 2008

    Report

    Report Number
    1625425-2008-00002
    Event Type
    Injury
    Date Received
    March 7, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    KNW
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE REMAINDER OF THE INFO WAS UNATTAINABLE FROM THE CUSTOMER. FROM THE SAMPLES PULLED FROM STOCK, THE ISSUE COULD NOT BE REPLICATED WHEN SUBJECTED TO INTENDED CLINICAL USAGES. THE ISSUE COULD BE REPLICATED WHEN THE DISTAL END OF THE FEP TUBING WAS INTENTIONALLY DAMAGED WITH A SHARP OBJECT. MARKETING REPRESENTATIVE THAT WENT TO THE ACCOUNT DISCUSSED USE OF AN ALTERNATE FORCEP DESIGN, PRODUCT CODE 00-190080, WHICH IS A DIFFERENT SHAFT DESIGN AND FEP (BLUE) TUBING IS MUCH THINNER AND ADHERES TO EACH COIL SEGMENT ALONG THE SHAFT LENGTH. THE PHYSICIAN FORMED A NON-STERILE SAMPLE USING HIS PRIMARY/SECONDARY ACUTE CURVE TECHNIQUE AND EXPRESSED INTEREST IN EVALUATING SAMPLES. SUPPLIER OF THESE DEVICES 100% VISUALLY AND FUNCTIONALLY INSPECTS THE PRODUCT PRIOR TO PACKAGING. TESTING CONDUCTED ON SAMPLES FROM INVENTORY COULD NOT REPLICATE THE FAILURE WITHOUT INDUCING SIGNIFICANT DAMAGE TO THE FEP TUBING. NO CORRECTIVE ACTION WILL BE TAKEN IN RESPONSE TO THIS ISSUE AS THE ACUTE BENDS OF THE FORCEPS CONTRIBUTED TO THIS RELATIVELY ISOLATED INCIDENT. THE SAMPLE WAS NOT RELEASED FOR INVESTIGATION. ARGON MARKETING EMPLOYEE AND SALES REPRESENTATIVE WENT TO THE ACCOUNT TO DISCUSS ISSUES WITH THE PHYSICIAN. MARKETING EMPLOYEE STATED, THE FOLLOWING ABOUT THE CONVERSATION WITH THE PHYSICIAN. "...THE PHYSICIAN WAS PERFORMING BIOPSY AND FEP (BLUE) TUBING BECAME DETACHED DURING DISTAL TIP FORMING PRIOR TO INSERTION. THE PHYSICIAN DESCRIBED HIS FORMING TECHNIQUE OF A PRIMARY AND SECONDARY CURVE WITH A VERY ACUTE DISTAL BEND. HE THOUGHT HIS FORMING TECHNIQUE MAY HAVE DETACHED TUBING AND COMPLETED BIOPSY WITHOUT INCIDENT. HE EXPRESSED CONCERN THAT HIS UNUSUAL FORMING TECHNIQUE MAY HAVE DAMAGED TUBING INTERFACE WITH CUTTING HEAD ASSEMBLY." TO INVESTIGATE IF THIS ISSUE COULD BE REPLICATED, 10 SAMPLES OF THE SAME PART NUMBER WERE PULLED FROM STOCK (P/N: 00-190081, L/N: 010818) AND TESTED. THE SAMPLES WERE VISUALLY INSPECTED TO ENSURE THAT THE DISTAL END OF THE FEB TUBING WAS ADEQUATELY ANCHORED AROUND THE HOUSING. ADDITIONALLY, THE FORCEPS WERE ALL FULLY ACTUATED TO ENSURE PROPER FUNCTIONALITY OF THE DEVICE. ALL 10 SAMPLES LOOKED AND WORKED AS INTENDED. THE SUPPLIER OF THESE DEVICES 100% VISUALLY AND FUNCTIONALLY INSPECTS THE PRODUCT PRIOR TO PACKAGING. NO CORRECTIVE ACTION WILL BE TAKEN IN RESPONSE AS THIS IS A RELATIVELY ISOLATED INCIDENT OF WHICH HANDLING DURING USE COULD HAVE CONTRIBUTED TO THE FAILURE. WILL MONITOR COMPLAINT FOR ANY RELATED ISSUES WITH THE ALTERNATE PRODUCT CODE PROPOSED TO THE ACCOUNT OR FOR ANY RELATED ISSUES AT OTHER ACCOUNTS.

    Description of Event or Problem · 1

    FORCEP DAMAGED PATIENT VALVE DURING PROCEDURE. THE BLUE FEP TUBING THAT IS SHRINK WRAPPED OVER THE LENGTH OF THE FORCEP ENDS AT THE DISTAL TIP BY BEING SECURED OVER A SHOULDER PRODUCED BY THE HOUSING. IN THIS CASE, THE FEP TUBING HAD BEEN DAMAGED SO THAT THE SHOULDER WAS NO LONGER SUFFICIENT TO SECURE THE FEP TUBING IN PLACE. THE RESULTS OF THIS OCCURRENCE IS THAT WHEN THE CORE WIRE AND OUTER COILS OF THE FORCEP ARE COMPRESSED (WHICH OCCURS WHEN THE JAWS ARE ACTUATED), THE COILS ARE ABLE TO EXPAND FURTHER THAN THE FEP TUBING AND BECOME EXPOSED. THIS RESULTED IN THE ENTRAPMENT OF VALVE MATERIAL BETWEEN THE FEP JACKET AND COIL. AS FORCEP WAS WITHDRAWN THE VALVE MATERIAL WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMB FORCEPS (JAWZ) BIOPSY FORCEPS KNW ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability