BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14601554 · Received June 6, 2022

    Report

    Report Number
    8010047-2022-09455
    Event Type
    Injury
    Date Received
    June 6, 2022
    Report Date
    July 12, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR AND THE LEGAL MANUFACTURER'S INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: B5, D4, H6, H10. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE USE OF ENDOSCOPIC CLIPPING IN PREVENTING DELAYED COMPLICATIONS AFTER ENDOSCOPIC RESECTION FOR SUPERFICIAL NON-AMPULLARY DUODENAL TUMORS". THIS RETROSPECTIVE COHORT STUDY DESCRIBED THE USE OF ENDOSCOPIC CLIPPING IN PREVENTING DELAYED COMPLICATIONS AFTER ENDOSCOPIC RESECTION FOR SUPERFICIAL NON-AMPULLARY DUODENAL TUMORS. PATIENTS WERE DIVIDED INTO 2 GROUPS: THE IMMEDIATE CLIPPING GROUP (ICG) AND THE NO CLIPPING GROUP (NCG). ENDOSCOPIC MUCOSAL RESECTION (EMR) AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WERE PERFORMED USING EITHER TWIN-CHANNEL MULTI-BENDING GASTROSCOPES (GIF-2TQ260M; OLYMPUS) OR CONVENTIONAL GASTROSCOPES (GIF-H260 OR GIF-HQ290; OLYMPUS). AN INITIAL INCISION WAS MADE OUTSIDE THE MARKS USING EITHER A DUAL KNIFE (KD-655; OLYMPUS) OR A HOOK KNIFE (KD-620LR; OLYMPUS). AFTER ER, THE MUCOSAL DEFECT WAS CLOSED USING CLIPS (HX-610-090L; OLYMPUS ) DELIVERED BY A CLIP-FIXING DEVICE (HX 110UR; OLYMPUS). A TOTAL OF 99 LESIONS FROM 99 PATIENTS WERE INCLUDED IN THIS STUDY. FIFTY-TWO PATIENTS WERE ALLOCATED INTO ICG AND 47 PATIENTS WERE ALLOCATED INTO NCG. DELAYED BLEEDING OCCURRED IN 1 PATIENT FROM ICG AND IN 8 PATIENTS FROM NCG. DELAYED PERFORATION OCCURRED IN 1 PATIENT FROM ICG AND IN 3 PATIENTS FROM NCG. THERE WERE NO PROCEDURE-RELATED DEATHS IN BOTH GROUPS. THIS STUDY CONCLUDED THAT ALTHOUGH THE USE OF ENDOSCOPIC CLIPPING SEEMED TO REDUCE THE RISK OF DEVELOPING DELAYED COMPLICATIONS, FURTHER STUDIES USING A PROSPECTIVE DESIGN IS REQUIRED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED PERFORATION (4), DELAYED BLEEDING (9), IMMEDIATELY COMPLICATION (PERFORATION N=1, BLEEDING N=5). THE AUTHORS USED SIX OLYMPUS DEVICES AND DID NOT SPECIFY WHICH DEVICE WAS USED ON THE PATIENTS WITH ADVERSE EVENTS. PATIENT IDENTIFIER (B)(6): GIF-2TQ260M, WE SELECTED "GIF-2TQ260M" AS A REPRESENTATIVE PRODUCT. PATIENT IDENTIFIER (B)(6): GIF-HQ290. PATIENT IDENTIFIER (B)(6): KD-655L, WE SELECTED "KD-655L" AS A REPRESENTATIVE PRODUCT. PATIENT IDENTIFIER (B)(6): KD-620LR. PATIENT IDENTIFIER (B)(6): HX-610-090L. PATIENT IDENTIFIER (B)(6): HX-110UR. THIS REPORT IS 1 OF 6 FOR PATIENT IDENTIFIER (B)(6): GIF-2TQ260M, WE SELECTED "GIF-2TQ260M" AS A REPRESENTATIVE PRODUCT.

    Description of Event or Problem · 0

    THE AUTHOR PROVIDED ADDITIONAL INFORMATION: THE AUTHOR RESPONDED WITH NO WHEN ASKED FOR MEDICAL OR SURGICAL INTERVENTION FOR THE REPORTED ADVERSE EVENTS. NO OLYMPUS DEVICE MALFUNCTIONED. IN THE OPINION OF THE AUTHOR, THE OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226889 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-2TQ260M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other LOT UNK: HX-610-090L OR HX-110UR| LOT UNK: KD-655L OR KD-620LR