BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIJ NEEDLE, TUMOR LOCALIZATION

    MDR report key: 8841477 · Received July 30, 2019

    Report

    Report Number
    1820334-2019-01858
    Event Type
    Injury
    Date Received
    July 30, 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. FDA REQUEST - AN FDA REQUEST TO CLARIFY PRODUCT INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6)2019. AFTER REVIEW, THE COMPLAINT DEVICE WAS LIKELY A KOPANS BREAST LOCALIZATION NEEDLE. THE SPECIFIC TYPE OF KOPANS BREAST LOCALIZATION NEEDLE IS UNABLE TO BE DETERMINED. D2 - COMMON DEVICE NAME: MIJ NEEDLE, TUMOR LOCALIZATION. D2B - PROCODE: MIJ. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    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: PRECAUTIONS: FOLLOWING THE PLACEMENT OF THE HOOKWIRE, THE PORTION PROTRUDING OUTSIDE OF THE BREAST SHOULD BE BENT AND TAPED TO THE SKIN TO PREVENT INADVERTENT MOVEMENT. INSTRUCTIONS FOR USE: BEND THE HOOKWIRE PROTRUDING FROM THE BREAST AND TAPE FLAT TO THE SKIN. VERIFY FINAL HOOKWIRE POSITION. BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF THE RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT UNINTENDED USE ERROR POSSIBLY CONTRIBUTED TO THIS EVENT. 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: PRODUCT INFORMATION CURRENTLY UNAVAILABLE. PMA/510(K) #: PRODUCT INFORMATION UNAVAILABLE. (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" MIGRATION AND SEPARATION 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 WOMAN HAD A SUSPICIOUS LEFT BREAST LESION ON ROUTINE MAMMOGRAPHIC EXAMINATION, AND LOCALIZATION WAS PERFORMED VIA A PERIAREOLAR APPROACH, AT A LATER DATE, WITH BIOPSY IMMEDIATELY FOLLOWING. THE SURGEON NOTED THAT THE WIRE WAS PRESENT AT THE START OF THE BIOPSY, BUT THE WIRE END DISAPPEARED DURING DISSECTION; THE WIRE COULD NOT BE FOUND IN THE SPECIMEN OR DURING EXPLORATION. AN INTRAOPERATIVE CHEST ROENTGENOGRAM WAS OBTAINED, BUT THE WIRE WAS NOT IDENTIFIED BY OPERATING ROOM PERSONNEL. IT WAS THOUGHT THAT THE WIRE MAY HAVE HOOKED ONTO A SPONGE DURING THE PROCEDURE. POSTOPERATIVE FLUOROSCOPY OF THE CHEST, BETTER TO EXCLUDE A RETAINED WIRE, SHOWED THE ORIGINAL LOCALIZER IN THE POSTERIOR UPPER INNER QUADRANT OF THE BREAST. A SECOND NEEDLE HOOK WIRE LOCALIZER WAS PLACED ADJACENT TO THE ORIGINAL AND BOTH WERE REMOVED. NEVERTHELESS, FOLLOW-UP MAM­MOGRAPHY SIX MONTHS LATER DISCLOSED THE DISTAL 1 CM OF HOOK WIRE STILL WITHIN THE BREAST. A SLIGHT CURVE AT THE END OF THE RETAINED FRAGMENT INDICATES BREAKAGE AT THE CURVED PORTION OF THE HOOK WIRE." 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634536 MIJ NEEDLE, TUMOR LOCALIZATION MIJ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R