BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 10288577 · Received July 17, 2020

    Report

    Report Number
    3005075853-2020-03618
    Event Type
    Injury
    Date Received
    July 17, 2020
    Report Date
    June 18, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE UNK. BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON/AUTHOR BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: SURGERY FOR KILLIAN-JAMIESON DIVERTICULUM: A REPORT OF TWO CASES. AUTHORS: KOHEI SAISHO, SATORU MATONO, TOSHIAKI TANAKA, NAOKI MORI, HARUHIRO HINO, MASAHIRO FUJISAKI, MASASHI NAKAGAWA, FUMIHIKO FUJITA AND YOSHITO AKAGI. CITATION: SURGICAL CASE REPORTS (2020) 6:17; HTTPS://DOI.ORG/10.1186/S40792-020-0789-0. THIS CASE STUDY PRESENTED A (B)(6) YEAR OLD WOMAN WITH A 1-YEAR HISTORY OF PROGRESSIVE PHARYNGEAL DISCOMFORT. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) REVEALED A DIVERTICULUM JUST UNDER THE ESOPHAGEAL ORIFICE. THE DIVERTICULUM WAS DIAGNOSED AS KJD BASED ON THESE ENDOSCOPIC AND RADIOGRAPHIC FINDINGS. THE PATIENT UNDERWENT DIVERTICULECTOMY. CRICOPHARYNGEUS MYOTOMY AND 2 CM OF PROXIMAL ESOPHAGEAL MYOTOMY WERE PERFORMED. AFTER THE MYOTOMY, THE DIVERTICULUM WAS RESECTED AT ITS BASE USING A LINEAR STAPLER (ETS-FLEX45, ETHICON). THE WOUND WAS IRRIGATED AND CLOSED WITH THE PLACEMENT OF A CLOSED SUCTION DRAIN. A GASTROGRAFFIN SWALLOW EXAMINATION ON POSTOPERATIVE DAY 6 REVEALED NO EVIDENCE OF LEAKAGE AND THE PATIENT STARTED ORAL INTAKE. HOWEVER, AT 1 MONTH AFTER SURGERY, SHE PRESENTED WITH LEFT CERVICAL REDNESS AND PAIN. A GASTROGRAFFIN SWALLOW EXAMINATION REVEALED STAPLE LINE LEAKAGE. HOWEVER, IT WAS CURED WITH FASTING AND PERCUTANEOUS ABSCESS DRAINAGE. AT 5 MONTHS AFTER SURGERY, THE PATIENT WAS ASYMPTOMATIC. IN CONCLUSION, THE FIRST CHOICE OF SURGERY FOR KJD IS DIVERTICULECTOMY BUT IN A HIGH-RISK PATIENT, DIVERTICULOPEXY IS A REASONABLE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754761 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention