BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 16158738 · Received January 13, 2023

    Report

    Report Number
    3006722112-2022-00138
    Event Type
    Death
    Date Received
    January 13, 2023
    Date of Event
    September 12, 2022
    Report Date
    December 28, 2022
    Manufacturer
    APOLLO ENDOSURGERY, INC
    Product Code
    OCW
    UDI-DI
    10811955020664
    PMA / PMN Number
    K081853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENT #01 MEDWATCH SUBMITTED TO THE FDA ON 27/MAR/2023. ADDITIONAL INFORMATION: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, AND AFTER MULTIPLE ATTEMPTS TO GATHER MORE INFORMATION FROM THE REPORTER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE INVESTIGATOR DETERMINED A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT POSSIBLE FOR THIS COMPLAINT, AS ATTEMPTS AT GATHERING THE DEVICE SERIAL/LOT NUMBER WERE UNSUCCESSFUL. AUTOPSY WAS REQUESTED BUT HAVE NOT RECEIVED REPORT. IF ONE IS RECEIVED THE REPORT WILL BE UPDATED. DEVICE EVALUATION SUMMARY: ASSESSMENT OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT POSSIBLE, AND IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 0

    INITIAL MEDWATCH SUBMITTED TO THE FDA ON 13/JAN/2023. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE APOLLO ENDOSURGERY OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM (ESS) IS INTENDED FOR ENDOSCOPIC PLACEMENT OF SUTURE(S) AND APPROXIMATION OF SOFT TISSUE. THE CURRENT OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM (ESS) INSTRUCTIONS FOR USE (IFU) ADDRESSED THE KNOWN AND POTENTIAL EVENT OF "SUTURE ASSEMBLY - SUTURE BROKE DURING PROCEDURE" AS FOLLOWS: 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. AN OVERTUBE WITH AN INTERNAL DIAMETER OF AT LEAST 16.7 MM MAY BE USED WITH THE SYSTEM TO PROTECT THE ESOPHAGUS. THE OVERSTITCH IS COMPATIBLE WITH THE FOLLOWING ENDOSCOPES: OLYMPUS 2T160, 2TH180, OR 2T240 FUJI EI-740D/S ADVERSE EVENTS POSSIBLE COMPLICATIONS THAT MAY RESULT FROM USING THE ENDOSCOPIC SUTURING SYSTEM INCLUDE, BUT MAY NOT BE LIMITED TO: ·PHARYNGITIS / SORE THROAT ·NAUSEA AND / OR VOMITING ·ABDOMINAL PAIN AND / OR BLOATING ·HEMORRHAGE. ·HEMATOMA. ·CONVERSION TO LAPAROSCOPIC OR OPEN PROCEDURE. ·STRICTURE. ·INFECTION / SEPSIS. ·PHARYNGEAL, COLONIC AND/OR ESOPHAGEAL PERFORATION. ·ESOPHAGEAL, COLONIC AND/OR PHARYNGEAL LACERATION. ·INTRA-ABDOMINAL (HOLLOW OR SOLID) VISCERAL INJURY ·ASPIRATION. ·WOUND DEHISCENCE. ·ACUTE INFLAMMATORY TISSUE REACTION. ·DEATH. NOTE: ANY SERIOUS INCIDENT THAT HAS OCCURRED IN RELATION TO THE DEVICE SHOULD BE REPORTED TO APOLLO ENDOSURGERY (SEE CONTACT INFORMATION AT THE END OF THIS DOCUMENT) AND ANY APPROPRIATE GOVERNMENT ENTITY. ADDITIONAL INFORMATION: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE INVESTIGATOR IS WAITING UNTIL THE LOT NUMBER OF THE DEVICE IS KNOWN TO DETERMINE WHETHER A DEVICE HISTORY RECORD (DHR) REVIEW IS OR IS NOT REQUIRED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    AFTER THE GEN 2 SURGERY, THE PATIENT STARTED BLOATING AND VITALS SIGNS DROPPED. THE PATIENT WAS MOVED TO ICU TO STABILIZED. THE PATIENT PASSED AWAY A SHORT WHILE LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751366 OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM SUTURING SYSTEM F OCW APOLLO ENDOSURGERY, INC ESS-G02-160 10811955020664

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Death