BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL KIT

    MDR report key: 3934851 · Received June 20, 2014

    Report

    Report Number
    1037905-2014-00251
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FBK
    PMA / PMN Number
    K111495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE SAFE AND EFFECTIVE USE OF THIS DEVICE IS HIGHLY DEPENDENT UPON FACTORS UNDER CONTROL OF THE OPERATOR. PRIOR TO DISTRIBUTION, ALL GEL KITS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. 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.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE PHYSICIAN USED A COOK GEL KIT. THE PHYSICIAN REPORTED A COMPLICATION DURING THE ESD CASE USING THE GEL KIT ON A LESION LOCATED AT THE GASTRO-ESOPHAGEAL JUNCTION. INITIAL INJECTION OF SALINE WAS PERFORMED AS PRACTICED IN OTHER AREA OF GI TRACT. THEN, GEL WAS INJECTED AT GASTRO-ESOPHAGEAL JUNCTION WITH BLEB ON STRAIGHT VIEW. DURING THE CASE, HE NOTICED SOME POCKETS CREATED BY THE GEL. THEY LOOKED LIKE THEY WERE CREATED WITHIN SUBMUCOSA BUT APPEARED DEEP. WHEN HE CUT INTO THE SUBMUCOSAL SPACE NEAR THE POCKETS, HE REALIZED THAT THEY WERE FORMED WITHIN THE MUSCULARIS PROPRIA AS HE COULD VISUALIZE THE SEROSA. IT WAS NOTED THAT THE MUSCLE WAS SPLIT AND THIS CAUSED PAIN TO THE PATIENT. THE DEEP POCKET APPEARED NOT TO HAVE PENETRATED THE SEROSA. AT THE END OF THE COMPLETED RESECTION, CLIPS AND ENDOSCOPIC SUTURES WERE PLACED TO PREVENT DELAYED PERFORATION AND A STENT WAS PLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE INJECTION INTO THE MUSCLE WAS PAINFUL TO THE PATIENT. THE PATIENT REQUIRED CLIPS, SUTURES AND A STENT DUE TO THIS OCCURRENCE. THE PATIENT WAS OBSERVED FOR 2 DAYS AND THEN DISCHARGED. THE PATIENT DID NOT REQUIRE ANY OTHER ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NO EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364207 GEL KIT FBK WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ENDOSCOPE (UNK TYPE)