BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM

    MDR report key: 13802294 · Received March 17, 2022

    Report

    Report Number
    3006722112-2022-00030
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    February 16, 2022
    Report Date
    February 18, 2022
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    OCW
    UDI-DI
    10811955020671
    PMA / PMN Number
    K081853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM (ESS) INSTRUCTIONS FOR USE (IFU) ADDRESSED THE KNOWN AND POTENTIAL EVENT OF "PERFORATION" AS FOLLOWS: WARNINGS: ONLY PHYSICIANS POSSESSING SUFFICIENT SKILL AND EXPERIENCE IN SIMILAR OR THE SAME TECHNIQUES SHOULD PERFORM ENDOSCOPIC PROCEDURES. CONTACT OF ELECTROSURGICAL COMPONENTS WITH OTHER COMPONENTS MAY RESULT IN INJURY TO THE PATIENT AND/OR OPERATOR AS WELL AS DAMAGE TO THE DEVICE AND/OR ENDOSCOPE. VERIFY COMPATIBILITY OF ENDOSCOPIC INSTRUMENTS AND ACCESSORIES AND ENSURE PERFORMANCE IS NOT COMPROMISED. PRECAUTIONS THE SYSTEM MAY ONLY BE USED IF PURCHASED FROM APOLLO ENDOSURGERY, INC. OR ONE OF ITS AUTHORIZED AGENTS. WITH THE ENDOSCOPIC SUTURING SYSTEM INSTALLED, THE ENDOSCOPE'S PRIMARY CHANNEL EFFECTIVELY BECOMES A 3.2 MM CHANNEL. ADVERSE EVENTS POSSIBLE COMPLICATIONS THAT MAY RESULT FROM USING THE ENDOSCOPIC SUTURING SYSTEM INCLUDE, BUT MAY NOT BE LIMITED TO: PHARYNGEAL, COLONIC AND/OR ESOPHAGEAL PERFORATION. ADDITIONAL INFORMATION: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE INVESTIGATOR DETERMINED THAT A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT, AS THERE ARE NO OTHER COMPLAINTS AGAINST THIS LOT NUMBER, AF04665.

    Additional Manufacturer Narrative · 0

    SUPPLEMENT #1 MEDWATCH SUBMITTED TO THE FDA ON 12/MAY/2022. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THIS COMPLAINT AS IT'S A REPORTABLE EVENT. THE SUBJECT PRODUCT MET ALL SPECIFICATIONS AND REQUIREMENTS IN EFFECT AT THE TIME OF MANUFACTURE. THERE ARE NO OTHER COMPLAINTS AGAINST THIS LOT NUMBER, AF04665 DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE APOLLO DEVICE ANALYSIS LABORATORY ON (B)(6)/2022. A CINCH WAS RETURNED DISMANTLED WITHOUT THE PLUNGER. PRIOR TO DECONTAMINATION, ENGINEERING VISUALLY INSPECTED THE DEVICE. THERE ARE NO MANUFACTURING ABNORMALITIES OBSERVED. THE WIRE BROKE BELOW THE HANDLE AND THE HANDLE TO WIRE IS STILL INTACT. THE COMPLAINT HAS BEEN VERIFIED AS THE DEVICE WAS RETURNED DAMAGED; HOWEVER, THE ROOT CAUSE IS UNKNOWN AS SEVERAL FACTORS COULD CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    WIRE REMAINED IN PATIENT WITH THE HELP OF APC THE WIRE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697011 OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM ENDOSCOPIC SUTURING SYSTEM OCW APOLLO ENDOSURGERY, INC. CNH-G01-000 AF04665 10811955020671

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female