BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKL, LIGATOR, HEMORRHOIDAL

    MDR report key: 10294726 · Received July 20, 2020

    Report

    Report Number
    1037905-2020-00280
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    June 15, 2016
    Report Date
    July 17, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VON WULFENN, M., HUELSEN, A., O¿ROURKE, T., SAAD, N., & GUPTA, S. (2016). DELAYED PERFORATION CAUSED BY ENDOSCOPIC CLIP FOLLOWING UNCOMPLICATED ENDOSCOPY RESECTION OF A LARGE SPORADIC NONAMPULLARY DUODENAL ADENOMA. ENDOSCOPY JOURNAL, 48(1), E211-E212. HTTP://DX.DOI.ORG/10.1055/S-0042-109053. CONCOMITANT MEDICAL PRODUCTS: SNAREMASTER SD-230U-20. 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: 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 INSTRUCTIONS FOR USE (IFU) POTENTIAL COMPLICATIONS STATE: "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY AND ENDOSCOPIC HEMOSTASIS INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST, HEMATEMESIS, TRANSIENT DYSPHAGIA, ASPIRATION PNEUMONIA, WOUND DEHISCENCE, MINIMAL ACUTE INFLAMMATORY TISSUE REACTION, TRANSITORY LOCAL IRRITATION, MIGRATION OF CLIP INTO THE BILE DUCT, AND ANATOMY DISRUPTION." PRIOR TO DISTRIBUTION, ALL INSTINCT ENDOSCOPIC HEMOCLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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. [(B)(4)-VON WULLFEN.PDF].

    Description of Event or Problem · 1

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT INVOLVING COOK INSTINCT ENDOSCOPIC HEMOCLIP. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. "A (B)(6)-YEAR-OLD WOMAN WAS REFERRED FOR RESECTION OF A SPORADIC, 60-MM, HIGH GRADE TUBULOVILLOUS ADENOMA IN THE DESCENDING DUODENUM. . . SUBMUCOSAL INJECTION OF GELOFUSINE, METHYLENE BLUE, AND DILUTED ADRENALINE...WAS FOLLOWED BY PIECEMEAL ENDOSCOPIC MUCOSAL RESECTION. . .MINOR BLEEDING FROM VESSELS ALONG THE LATERAL RESECTION MARGIN SETTLED SPONTANEOUSLY, AND TWO CLIPS (INSTINCT HEMOCLIP; COOK MEDICAL, LIMERICK, IRELAND) WERE PLACED, TAKING CARE TO GRASP ADJACENT MUCOSA." FIG. 3 A HEMOSTATIC CLIP (INSTINCT ENDOSCOPIC HEMOCLIP; COOK MEDICAL, LIMERICK, IRELAND) WAS PLACED OVER THE VESSEL. A SECOND CLIP WAS PLACED FURTHER DISTALLY. . .OVERNIGHT THE PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER. COMPUTED TOMOGRAPHY SCAN SHOWED A MODERATE AMOUNT OF FREE RETROPERITONEAL AIR AND FLUID CONSISTENT WITH DUODENAL PERFORATION. . .INTRAOPERATIVE FINDINGS REVEALED THAT ONE CLIP HAD PERFORATED THE DUODENUM [SUBJECT OF REPORT], AND WAS PROTRUDING INTO THE RETROPERITONEUM. THE AREA WAS DEBRIDED AND DUODENAL EXCLUSION WAS PERFORMED. THE PERFORATION WAS MANAGED WITH T-TUBE PLACEMENT INTO THE DUODENAL LUMEN." AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT HAD A DEBRIDEMENT AND DUODENAL EXCLUSION THAT REQUIRED A T TUBE PLACEMENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DEVELOPED FEVER, ABDOMINAL PAIN, AND DUODENAL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763479 PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention EVIS EXERA II 180 DUODENOSCOPE