BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 11734204 · Received April 27, 2021

    Report

    Report Number
    1820334-2021-01236
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    July 15, 2020
    Report Date
    November 11, 2021
    Manufacturer
    COOK INC
    Product Code
    MIJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D4: LOT NUMBER IS NOT AVAILABLE. ADDITIONAL INFORMATION: D4, B5. 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. (B)(6) HOSPITAL IN TAIWAN INFORMED COOK OF AN INCIDENT INVOLVING A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE (DKBL-20-5.0-A) FROM AN UNKNOWN LOT. THE REPORTED NEEDLE WAS BROKEN AND LEFT IN THE PATIENT¿S BREAST DURING A BREAST LESION LOCALIZATION AND TUMOR REMOVAL ON (B)(6) 2020. IN 2021, IT WAS NOTED THAT PART OF THE NEEDLE WAS STILL LOCATED IN THE PATIENT'S BREAST. AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE NEEDLE AND CLEAR THE SURROUNDING TISSUES. THE PATIENT DID NOT EXPERIENCE ADDITIONAL ADVERSE EFFECTS. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE 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. A DEVICE MASTER RECORD (DMR) REVIEW WAS PERFORMED, AND DEVICE MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_DKBL_REV3] ¿KOPANS BREAST LESION LOCALIZATION NEEDLES,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE: NOTE: THE BURNISH MARK ON THE HOOKWIRE SHOULD BE SEEN JUST OUTSIDE THE NEEDLE HUB TO ENSURE THAT THE HOOKWIRE IS WITHIN THE NEEDLE TIP DURING NEEDLE MANIPULATION. 1.INTRODUCE THE NEEDLE INTO THE LESION. 2.CHECK THE POSITION OF THE NEEDLE. 3.ADVANCE AND RELEASE THE HOOKWIRE. 4.REMOVE THE NEEDLE. 5.BEND THE HOOKWIRE PROTRUDING FROM THE BREAST AND TAPE FLAT TO THE SKIN. 6.VERIFY FINAL HOOKWIRE POSITION. HOW SUPPLIED. ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THE LOT NUMBER OF THE DEVICE IS NOT KNOWN. A DATABASE SEARCH FOR LOTS SOLD TO THE CUSTOMER FOR THE REPORTED RPN OVER THE PAST 3 YEARS COULD NOT DETERMINE THE AFFECTED LOT FOR THIS COMPLAINT. AT THIS TIME, COOK CONCLUDED THAT NO NONCONFORMING PRODUCT FROM THE AFFECT LOT EXISTS IN HOUSE OR IN THE FIELD. THERE IS NO EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE 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

    ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2021. THE PLACEMENT OF THE HOOK WIRE WAS COMPLETED IN (B)(6) 2020. AT THE CONCLUSION OF THE PROCEDURE TO PLACE THE HOOK WIRE, THE NEEDLE WAS SECURED TO THE PATIENT USING AN ELASTIC BANDAGE. AFTER THE PLACEMENT OF THE HOOK WIRE, BUT DURING THE INITIAL SURGERY TO REMOVE THE TUMOR TISSUE, THE DOCTOR OPENED A WOUND NEAR THE NEEDLE AND REMOVED THE TUMOR AND THE NEEDLE AT THE SAME TIME. THE TUMOR TISSUE WAS REMOVED DURING THE INITIAL SURGERY BY OPENING THE WOUND (TRADITIONAL SURGERY). NO IMAGING CAN BE PROVIDED. THE PORTION OF THE NEEDLE LEFT IN THE PATIENT WAS DISCOVERED IN 2021 WHEN THE "GS" DOCTOR CUT THE SECTIONS FOR INSPECTION. THE SEPARATED PORTION OF THE DEVICE WAS REMOVED BY COMPLETING AN ADDITIONAL SURGERY AND IT WAS COMPLETED THE SAME WAY AS THE INITIAL SURGERY (OPENING THE WOUND AND REMOVING THE TISSUE/TRADITIONAL SURGERY). THE PATIENT WAS REPORTED TO BE BACK TO NORMAL AND COULD GO TO WORK AS BEFORE.

    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

    IMPLANT DATE: (B)(6) 2020. PMA/510(K) #: EXEMPT. 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

    IT WAS REPORTED A PATIENT REQUIRED A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE FOR BREAST LESION LOCALIZATION PRIOR TO REMOVAL OF A BREAST TUMOR. THE NEEDLE WAS SUCCESSFULLY PLACED. DURING THE TUMOR REMOVAL PROCEDURE, THE NEEDLE WAS BROKEN. DURING A RETURN VISIT, THE PHYSICIAN FOUND A PART OF THE NEEDLE REMAINED WITHIN THE PATIENT'S BREAST. AN ADDITIONAL PROCEDURE WAS CONDUCTED TO REMOVE THE PORTION OF THE WIRE AND "[CLEAR] SURROUNDING TISSUE UP." NO OTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627929 KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE MIJ NEEDLE, TUMOR LOCALIZATION MIJ COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O