BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIJ NEEDLE, TUMOR LOCALIZATION

    MDR report key: 8845907 · Received July 31, 2019

    Report

    Report Number
    1820334-2019-01879
    Event Type
    Injury
    Date Received
    July 31, 2019
    Report Date
    October 10, 2019
    Manufacturer
    COOK INC
    Product Code
    MIJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. THE PRODUCT¿S DESIGN HISTORY FILE WAS REVIEWED AND THE RISKS ASSOCIATED WITH THIS DEVICE WERE ACCEPTABLE WHEN WEIGHTED AGAINST THE BENEFITS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. SINCE NEITHER NONCONFORMANCES NOR OTHER COMPLAINTS FROM THE COMPLAINT DEVICE¿S LOT COULD BE CONFIRMED, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH NOTES: INTENDED USE: THE KOPANS BREAST LESION LOCALIZATION NEEDLE IS INTENDED FOR PREOPERATIVE MARKING OF NONPALPABLE BREAST LESIONS. BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE CONTRIBUTED TO THE FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: DEVICE IS LIKELY A KOPANS BREAST LOCALIZATION NEEDLE. THE SPECIFIC TYPE OF KOPANS BREAST LOCALIZATION NEEDLE IS UNABLE TO BE DETERMINED. PMA/510(K) #: PREAMENDMENT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE BELOW DESCRIPTION OF A KOPANS "SPRING HOOK LOCALIZER" SEPARATION AND MIGRATION WAS TAKEN FROM THE FOLLOWING LITERATURE ARTICLE: BRONSTEIN, ANDREW, RAY KILCOYNE AND ROGER MOE. "COMPLICATION OF NEEDLE LOCALIZATION OF FOREIGN BODIES AND NONPALPABLE BREAST LESIONS." ARCH SURG 123 (1988): 775-779. THE FOLLOWING WAS STATED IN THE ARTICLE: "A (B)(6) YEAR OLD MAN PRESENTED WITH A TEN-YEAR-OLD BULLET FRAGMENT IN THE LEFT LATERAL THIGH, 16 CM DISTAL TO THE GREATER TROCHANTER, FOR SURGICAL REMOVAL. BEFORE THE PROCEDURE, A NEEDLE HOOK WIRE LOCALIZER WAS PLACED ADJACENT TO THE BULLET FRAGMENT, UNDER FLUOROSCOPIC GUIDANCE, WITH 7 CM OF WIRE PROTRUDING FROM THE SKIN. THE HOOK WIRE WAS NOT FOUND AT THE TIME OF SURGERY, AND IT WAS ASSUMED BY THE SURGEON THAT THE WIRE HAD BEEN PULLED OUT DURING TRANSPORT, DURING SPINAL ANESTHESIA INDUCTION, OR AT SKIN PREPARATION. THE BULLET FRAGMENT WAS LOCALIZED AND EXCISED IN THE OPERATING ROOM BY PROBING WITH A NEEDLE THROUGH THE LOCALIZATION PUNCTURE SITE. TWO WEEKS LATER, THE PATIENT PRESENTED WITH KNEE PAIN, AND ROENTGENOGRAPHIC VIEWS DISCLOSED THE ENTIRE HOOK WIRE, BROKEN AT THE CURVED END, WITH ITS TIP AT THE LEVEL OF THE TIBIAL PLATEAU. BOTH FRAGMENTS WERE REMOVED UNDER FLUOROSCOPIC GUIDANCE BY A SMALL SKIN INCISION OVERLYING THE KNEE." ADDITIONAL ISSUES REGARDING THIS DEVICE FOUND IN THE LITERATURE ARTICLE ARE REPORTED UNDER ADDITIONAL MEDWATCH REPORTS. THESE MEDWATCH REPORTS CAN BE IDENTIFIED BY PATIENT IDENTIFIER (B)(6) AND PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639211 MIJ NEEDLE, TUMOR LOCALIZATION MIJ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention