BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELPOINT® MINI ADVANCED ACCESS PLATFORM

    MDR report key: 23176216 · Received September 29, 2025

    Report

    Report Number
    2027111-2025-00786
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 15, 2025
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K191866
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCE'S THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATIONS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE EVENT DEVICE IS ANTICIPATED TO RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LEFT COLECTOMY. EVENT DESCRIPTION: THE PRODUCT HAS BEEN SET ASIDE TO BE SENT BACK AS WELL IF NEED BE. PRODUCT: GELPOINT MINI, LOT#: 1552961, EXPIRATION: 04-21-2028, CASE TYPE: LEFT COLECTOMY, DATE: ON (B)(6) 2025, DOCTOR: DR. [NAME]. FAILURE: ALEXIS THAT CAME WITH THE PACK HAD A TEAR IN THE SHEATH TOWARDS THE TOP OF THE OUTER RING. REP INVOLVEMENT: YES, REP (MYSELF) WAS PRESENT DURING CASE TO VERIFY ALL DETAILS. HARM TO PATIENT? NO, THE FAILURE DID NOT HARM PATIENT AND THEY WERE ABLE TO COMPLETE THE PROCEDURE. DETAILED DESCRIPTION: DR. [NAME] IS VERY SKILLED AT SINGLE-SITE SURGERY AND USES THE GELPOINT MINI FOR ALL OF HIS CASES. INCISION WAS CREATED. ALEXIS FROM THE GELPOINT MINI KIT WAS PLACED INTO THE INCISION SITE AND ROLLED TIGHT GEL CAP HAD TROCARS INSERTED AND THEN THE CAP WAS PLACED ONTO THE SEATED ALEXIS OUTER RING DURING INSUFFLATION, THE INSUFFLATOR WAS TURNED ON TO NORMAL INSUFFLATION LEVELS AND YOU CAN HEAR THE GAS ESCAPING THROUGH THE GELPOINT MINI. THE PRODUCT WAS NOT FULLY INSUFFLATING. DOCTOR INCREASED THE FLOW ON THE INSUFFLATOR TO TRY TO BRING THE GEL UP TO A REASONABLE PRESSURE TO TRY TO BEGIN THE PROCEDURE. DOCTOR TRIED TO WORK THROUGH THE BEGINNING STAGES OF PROCEDURE, BUT THE GELPOINT WAS NOT KEEPING PRESSURE. AFTER TAKING OFF THE CAP, UNROLLING THE ALEXIS, THEY DISCOVERED THAT THERE WAS A SMALL HOLE IN THE TOP OF THE ALEXIS BY THE OUTER RING. DOCTOR USED ANOTHER GELPOINT MINI KIT AND HAD NO ISSUES CONTINUING WITH THE CASE. WHEN THE ALEXIS WAS PLACED IN, NO SURGICAL INSTRUMENTS HAD TOUCHED THE SHEATH OR WERE INSERTED THROUGH THE TROCARS PRIOR TO THE LEAK. INTERVENTION: DOCTOR USED ANOTHER GELPOINT MINI KIT AND HAD NO ISSUES CONTINUING WITH THE CASE. PATIENT STATUS: NO, THE FAILURE DID NOT HARM PATIENT.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LEFT COLECTOMY EVENT DESCRIPTION: THE PRODUCT HAS BEEN SET ASIDE TO BE SENT BACK AS WELL IF NEED BE. PRODUCT: GELPOINT MINI LOT #: 1552961 EXPIRATION: 04-21-2028 CASE TYPE: LEFT COLECTOMY DATE: (B)(6) 2025 DOCTOR: DR. [NAME] FAILURE: ALEXIS THAT CAME WITH THE PACK HAD A TEAR IN THE SHEATH TOWARDS THE TOP OF THE OUTER RING REP INVOLVEMENT: YES, REP (MYSELF) WAS PRESENT DURING CASE TO VERIFY ALL DETAILS HARM TO PATIENT?: NO, THE FAILURE DID NOT HARM PATIENT AND THEY WERE ABLE TO COMPLETE THE PROCEDURE DETAILED DESCRIPTION: DR. [NAME] IS VERY SKILLED AT SINGLE-SITE SURGERY AND USES THE GELPOINT MINI FOR ALL OF HIS CASES. INCISION WAS CREATED ALEXIS FROM THE GELPOINT MINI KIT WAS PLACED INTO THE INCISION SITE AND ROLLED TIGHT GEL CAP HAD TROCARS INSERTED AND THEN THE CAP WAS PLACED ONTO THE SEATED ALEXIS OUTER RING DURING INSUFFLATION, THE INSUFFLATOR WAS TURNED ON TO NORMAL INSUFFLATION LEVELS AND YOU CAN HEAR THE GAS ESCAPING THROUGH THE GELPOINT MINI. THE PRODUCT WAS NOT FULLY INSUFFLATING. DOCTOR INCREASED THE FLOW ON THE INSUFFLATOR TO TRY TO BRING THE GEL UP TO A REASONABLE PRESSURE TO TRY TO BEGIN THE PROCEDURE. DOCTOR TRIED TO WORK THROUGH THE BEGINNING STAGES OF PROCEDURE, BUT THE GELPOINT WAS NOT KEEPING PRESSURE. AFTER TAKING OFF THE CAP, UNROLLING THE ALEXIS, THEY DISCOVERED THAT THERE WAS A SMALL HOLE IN THE TOP OF THE ALEXIS BY THE OUTER RING. DOCTOR USED ANOTHER GELPOINT MINI KIT AND HAD NO ISSUES CONTINUING WITH THE CASE. WHEN THE ALEXIS WAS PLACED IN, NO SURGICAL INSTRUMENTS HAD TOUCHED THE SHEATH OR WERE INSERTED THROUGH THE TROCARS PRIOR TO THE LEAK INTERVENTION: DOCTOR USED ANOTHER GELPOINT MINI KIT AND HAD NO ISSUES CONTINUING WITH THE CASE. PATIENT STATUS: NO, THE FAILURE DID NOT HARM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113822 GELPOINT® MINI ADVANCED ACCESS PLATFORM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CNGL3 1552961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TROCAR.