BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4190 FCL S&N EP-1/POWER -NS

    MDR report key: 4221125 · Received November 3, 2014

    Report

    Report Number
    1221934-2014-00476
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK HAS NOT RECEIVED THIS DEVICE FOR EVALUATION AND IT IS UNKNOWN IF THE DEVICE HAS BEEN RETURNED. HOWEVER, IT WAS REPORTED THAT THE INTERFACE CABLE WS FAULTY LEADING TO THE REPORTED FAILURE DURING THE PROCEDURE. WITHOUT PHYSICAL EVALUATION, A DEFINITE ROOT CAUSE FOR THIS DEVICE FAILURE CANNOT BE DETERMINED. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    CUSTOMER IS COMPLAINING ABOUT: FMS FOOTPEDAL 4 WAY DOESN'T WORK. THE PUMP AND SHAVER POWER OFF --->PROBABLY CONTACT ISSUE. CONSEQUENCES: WAS THE PROCEDURE INTERRUPTED? NO. WAS AN ALTERNATIVE TECHNIQUE USED? NO. WAS A NEW DEVICE USED? IF YES, WHICH ONE? NO. THEY HAVE NO OTHER FOOTPEDALE. WAS THE PATIENT'S CONDITION ADVERSELY AFFECTED? YES. PROCEDURE EXTENDED THE INTERVENTION TOOK 1H40 INSTEAD OF 20 MIN IN NORMAL CASE :HOW IS DOING THE PATIENT? SHE WILL CHECK WITH PHYSICIAN ADD'L INFO (OCD RPT.) PHSP - ZFPEDAL4 - DNR - PROBLEM STATEMENT: CUSTOMER IS COMPLAINING ABOUT: FMS FOOTPEDAL 4 WAY DOESN'T WORK. THE PUMP AND SHAVER POWER OFF --->PROBABLY CONTACT ISSUE CONTACT DETAILS: CONTACT TITLE: BIOMED PHYSICIAN NAME: DR (B)(6) PHYSICIAN TEL. NO.: NOT PROVIDED COMPLAINT DETAILS DATE INCIDENT OCCURRED: NOT PROVIDED TYPE OF PROCEDURE/INTERVENTION: KNIE ARTHROSCOPY BEFORE, DURING, AFTER THE PROCEDURE? DURING THE PROCEDURE WAS THE DEVICE USED ON THE PATIENT? YES. CONSEQUENCES: WAS THE PROCEDURE INTERRUPTED? NO WAS AN ALTERNATIVE TECHNIQUE USED? NO WAS A NEW DEVICE USED? IF YES, WHICH ONE? NO. THEY HAVE NO OTHER FOOTPEDALE WAS THE PATIENT'S CONDITION ADVERSELY AFFECTED? YES. PROCEDURE EXTENDED THE INTERVENTION TOOK 1H40 INSTEAD OF 20 MIN IN NORMAL CASE :HOW IS DOING THE PATIENT? SHE WILL CHECK WITH PHYSICIAN . CUST ASKED FOR AN LOAN EQUIPMENT URGENTLY SHE NEEDS VERY QUICKLY A COST ESTIMATE (TODAY) AND ANOTHER FOOTPEDALE EMAIL FOR COST ESTIMATE (B)(4). I WILL TRANSMIT TO POLE EQUIPMENT ADDITIONAL INFORMATION PROVIDED BY OCD: CALLED CUSTOMER BACK THIS MORNING AND GET INTERESTING INFORMATIONS: ASKED IF SHE SEND THE FOOT PEDAL BACK AND TO WHOM SHE ADDRESS IT THEY SEND IT TO: ETHICON (B)(4). SHE EXPLAIN ME THAT THEY FOUND THE ISSUE , IT WAS NOT DUE TO THE FOOT PEDAL BUT IT WAS DUE TO A DEFECTIVE CABLE THAT WAS CONNECTED IN THE BACK OF THE FMS PUMP AND NOT USED ANYMORE AS IT ALLOWS TO CONNECT AN ADDITIONAL FOOT PEDAL SINCE THEY REMOVED THIS DAMAGED CABLE IT WORKS WELL. REFERENCE FROM THIS CABLE IS (B)(4). SO THE ISSUE WAS NOT DUE TO THE FOOT PEDAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702420 4190 FCL S&N EP-1/POWER -NS FMS ACCESSORIES HRX DEPUY MITEK NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other