BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL KIT

    MDR report key: 4121351 · Received September 19, 2014

    Report

    Report Number
    1037905-2014-00366
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 22, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FBK
    PMA / PMN Number
    K111495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INVESTIGATION IS ON-GOING. WE ARE IN THE PROCESS OF GATHERING MORE INFO REGARDING THE DESCRIPTION OF THE EVENT AND PATIENT OUTCOME. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THAT INFO IS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE ARE IN THE PROCESS OF GATHERING MORE INFO REGARDING THE DESCRIPTION OF THE EVENT AND PATIENT OUTCOME. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THAT INFO IS RECEIVED. 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. PRIOR TO DISTRIBUTION, ALL GEL KIT'S ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: THE NEED FOR CORRECTIVE ACTIONS IS STILL TO BE DETERMINED. WE ARE IN THE PROCESS OF GATHERING MORE INFO REGARDING THE DESCRIPTION OF THE EVENT AND PATIENT OUTCOME IN ORDER TO DETERMINE IF CORRECTIVE ACTIONS ARE REQUIRED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THAT INFO IS RECEIVED. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES REPORTED DURING THE TIME PERIOD REVIEWED. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE PHYSICIAN USED A COOK GEL KIT. THE PHYSICIAN USED THE GEL-K AS A LIFTING AGENT IN THE PROXIMAL/MID RECTUM. A PRE-LIFT WITH SALINE WAS ESTABLISHED PRIOR TO INJECTION OF THE GEL. THE PROCEDURE WAS COMPLETED, BUT NEW FINDINGS DURING THE END OF THE PROCEDURE MANDATED SURGERY. IN THIS CASE, THE SURGERY WAS A NORMAL NEXT CLINICAL STEP. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE NEXT TWO DAYS AND THEN DISCHARGED. THE PATIENT CAME BACK TO THE HOSPITAL ON (B)(6) 2014 WITH FEVER. THE PATHOLOGY RESULTS SHOWED A MICRO-PERFORATION. THE PHYSICIAN CONCLUDED THAT A DELAYED PERFORATION OCCURRED. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT PROVIDED AT THIS TIME. THE PHYSICIAN CONCLUDED THAT A DELAYED PERFORATION WITH FEVER HAD OCCURRED. ADDITIONAL INFO HAS BEEN REQUESTED REGARDING THE SURGERY AND PATIENT OUTCOME BUT NOT PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583766 GEL KIT FBK, ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK WILSON-COOK MEDICAL INC UNK

    Patients

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