BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTURA HOT BIOPSY FORCEPS

    MDR report key: 20822194 · Received December 2, 2024

    Report

    Report Number
    1037905-2024-00773
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    October 31, 2024
    Report Date
    December 2, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KGE
    UDI-DI
    00827002315839
    PMA / PMN Number
    K171973
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION G: 510K: K171973. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: THE INFORMATION PROVIDED INDICATED THAT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION, THE HOT BIOPSY FORCEP WAS USED FOR HEMOSTASIS. USE OF THE DEVICE FOR HEMOSTASIS IS AGAINST THE INTENDED USE AND IS MOST LIKELY THE CAUSE FOR THE REPORTED OBSERVATION. THE INTENDED USE STATES, "THIS DEVICE IS USED ENDOSCOPICALLY IN CONJUNCTION WITH MONOPOLAR ELECTROSURGICAL CURRENT TO OBTAIN GASTROINTESTINAL MUCOSAL TISSUE BIOPSIES AND FOR REMOVAL OF SESSILE POLYPS. NOTE: DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE." PRIOR TO DISTRIBUTION, ALL HOT CAPTURA BIOPSY FORCEPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE PROPER WORKABILITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT THE FORCEPS WERE USED FOR HEMOSTASIS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION AND USE OF THE DEVICE FOR HEMOSTASIS IS AGAINST THE INTENDED USE, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION OF THE ESOPHAGUS [ABNORMAL USE], THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS. THE LESION WAS SEPARATED BY THERMAL BIOPSY FORCEPS TO STOP BLEEDING, AND THE FRONT END OF THE BIOPSY FORCEPS WAS SUDDENLY BENT AND BROKEN, RESULTING IN THE RUPTURE OF THE BLOOD VESSEL, AND THE MUSCLE OF THE ESOPHAGEAL WALL WHERE THE BLOOD VESSEL WAS LOCATED PENETRATED WOUND. BLEEDING CONTROL [WAS REQUIRED]. USER IMMEDIATELY REPLACE WITH A NEW BIOPSY FORCEPS AND CLIP THE RUPTURED VESSEL TO STOP BLEEDING WITH A TITANIUM CLIP. NO OTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132231 CAPTURA HOT BIOPSY FORCEPS KGE, FORCEPS, BIOPSY, ELECTRIC KGE WILSON-COOK MEDICAL INC G31583 W4826044 00827002315839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ENDOSCOPE-UNKNOWN MAKE OR MODEL