BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIJ NEEDLE, TUMOR LOCALIZATION

    MDR report key: 8854559 · Received August 2, 2019

    Report

    Report Number
    1820334-2019-01906
    Event Type
    Injury
    Date Received
    August 2, 2019
    Report Date
    September 20, 2019
    Manufacturer
    COOK INC
    Product Code
    MIJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. A REVIEW OF DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. HOWEVER, COOK RECEIVED A COMPLAINT FOR A SIMILAR PRODUCT EXPERIENCING A SIMILAR FAILURE MODE IN COMPLAINT CAPTURED UNDER MEDWATCH REPORT #1820334-2017-03791. THE PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE IN THE SIMILAR COMPLAINT FOUND ONE BBL-10-15.0-DKBL-A HOOK WIRE WAS RETURNED IN AN OPEN AND USED CONDITION. NO NEEDLE WAS RETURNED. THE HOOK WIRE IS SEPARATED INTO TWO PIECES. THE HOOK ITSELF IS NOT INTACT ON EITHER PIECE. THE TWO PIECES HAVE SEPARATED WITHIN THE ETCHED MARK SECTION OF THE HOOK WIRE. THE INVESTIGATION UNDER MEDWATCH REPORT #1820334-2017-03791 CONCLUDED THAT THE CAUSE OF THE FAILURE COULD NOT BE ESTABLISHED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. A GLOBAL SALES SHIPMENT REPORT COULD NOT BE CONDUCTED OVER THE TIME PERIOD THIS COMPLAINT OCCURRED. THE COMPLAINT OCCURRED 20-30 YEARS AGO AND COOK WAS UNABLE TO NARROW DOWN THE LOT THIS COMPLAINT PERTAINS TO. DUE TO MISSING INFORMATION AND TIME SINCE THIS COMPLAINT OCCURRED, THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, THE CAUSE WAS TRACED TO COMPONENT FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    DATE OF EVENT: PER THE ARTICLE, EVENTS OCCURRED SOMETIME BETWEEN (B)(6) 1987 AND (B)(6) 1996. SUSPECT MEDICAL DEVICE: SPECIFIC PRODUCT INFORMATION CURRENTLY UNAVAILABLE. HOWEVER, DEVICE IS LIKELY A COOK (B)(6) BREAST LESION LOCALIZATION NEEDLE. INITIAL REPORTER: (B)(6). CONTACT INFORMATION LISTED FOR (B)(6) HOSPITAL UNKNOWN. OCCUPATION: UNKNOWN. 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 WIRE MIGRATION USING A KOPANS BREAST LESION LOCALIZATION NEEDLE WAS TAKEN FROM THE FOLLOWING ARTICLE: ROVERE, G QUERCI DELLA, JR BENSON, M MORGAN, ET AL. "LOCALIZATION OF IMPALPABLE BREAST LESIONS - A SURGICAL APPROACH." ESJO 22 (1996): 478-482. THE ARTICLE MENTIONS THE "COOK WIRE" WAS USED FOR LOCALIZATION OF BREAST LESIONS. ALTHOUGH THE EXACT PRODUCT INFORMATION CANNOT DETERMINED, THE PRODUCT IS LIKELY A KOPANS BREAST LOCALIZATION NEEDLE. THE FOLLOWING IS STATED IN THE ARTICLE: "A TOTAL OF 665 GUIDE-WIRE LOCALIZED BIOPSIES HAVE BEEN CARRIED OUT AT ST. MARGARET'S HOSPITAL, EPPING AND THE ROYAL MARSDEN HOSPITAL, SUTTON BETWEEN 1 NOVEMBER 1987 AND 31 MARCH 1995, AND BETWEEN 1 JANUARY 1994 AND 31 MARCH 1996 RESPECTIVELY...." "USING THE DESCRIBED METHOD, THESE LESIONS WERE SUCCESSFULLY LOCALIZED IN 90% OF CASES...AND NO PATIENTS LEFT THE OPERATING THEATRE WITHOUT THEIR LESION HAVING BEEN COMPLETELY REMOVED." "MIGRATION OF THE WIRE OCCURRED IN TWO PATIENTS BOTH OF WHOM WERE OBESE WITH LARGE BREASTS. THESE 'ROGUE' WIRES PROVED QUITE TROUBLESOME TO LOCATE DUE TO THEIR FINE NATURE AND POOR RADIOLOGICAL VISUALIZATION. HOWEVER, BOTH WIRES WERE EVENTUALLY SUCCESSFULLY RETRIEVED, ONE BEING CONFINED WITHIN THE BREAST TISSUE, BUT THE OTHER HAVING MIGRATED INTO THE POSTERIOR TRIANGLE OF THE CONTRALATERAL NECK." THE PATIENT WITH THE WIRE MIGRATING WITHIN THE BREAST TISSUE IS RECORDED UNDER THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6). THE PATIENT WITH THE WIRE MIGRATING INTO THE POSTERIOR TRIANGLE OF THE CONTRALATERAL NECK IS RECORDED UNDER THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6). PER THE ARTICLE, THE LESIONS WERE COMPLETELY REMOVED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THESE INCIDENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648792 MIJ NEEDLE, TUMOR LOCALIZATION MIJ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention