MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GELPOINT® MINI ADVANCED ACCESS PLATFORM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CNGL3
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopy myomectomy.Event description: after proper placement of the cngl3, a minor gas leak was noted but did not initially impact the procedure.However, a significant loss of pneumoperitoneum occurred when attempting to insert a specimen retrieval bag.The gelseal cap was then opened as part of the standard procedure to facilitate the retrieval of the myoma.Upon opening, it was discovered that the valve from the sleeve had detached and fallen into the patient's abdominal cavity.The valve was successfully retrieved by the surgeon.Relevant photos are attached for your reference.There is no impact to patient.No intervention was required.There is no other instruments to affect this event.Additional information provided by [distributor] on 08oct2025 via email: no, this was not a robotic surgery.No, an airseal insufflator was not used.The co2 leakage was persistent.Standard 5mm instruments and a 5mm laparoscope were used throughout the procedure.Initially, the leak appeared to originate from the periphery of the alexis wound protector.Subsequently, a massive leak occurred due to the complete detachment of the trocar's valve.The entire valve detached intact (photos attached).The component was clear/transparent.Yes, the surgeon attempted to resolve the initial leakage by packing gauze around the interface of the alexis wound protector.The insufflator pressure was set to 13 mmhg, with the flow rate set to maximum.No, a visual inspection revealed no apparent damage on the gelseal cap.Intervention: ni patient status: there is no impact to patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the shield dislodgment, a plastic internal component, from the seal subassembly, resulting in the leakage.During visual inspection also sheath tears on alexis were observed.Based on the condition of the returned unit, it is likely that the reported event was caused by an asymmetrical and sharp object or instrument that was introduced non-axially.The instructions for user states, "all instruments should be centered axially when inserted through the sleeve¿s seal to avoid potential damage to sleeve" and "avoid sharp instruments contacting the alexis o wound protector-retractor as they may damage the wound retractor or cause patient injury." applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: laparoscopy myomectomy.Event description: after proper placement of the cngl3, a minor gas leak was noted but did not initially impact the procedure.However, a significant loss of pneumoperitoneum occurred when attempting to insert a specimen retrieval bag.The gelseal cap was then opened as part of the standard procedure to facilitate the retrieval of the myoma.Upon opening, it was discovered that the valve from the sleeve had detached and fallen into the patient's abdominal cavity.The valve was successfully retrieved by the surgeon.Relevant photos are attached for your reference.There is no impact to patient.No intervention was required.There is no other instruments to affect this event.Additional information provided by [distributor] on 08oct2025 via email: no, this was not a robotic surgery.No, an airseal insufflator was not used.The co2 leakage was persistent.Standard 5mm instruments and a 5mm laparoscope were used throughout the procedure.Initially, the leak appeared to originate from the periphery of the alexis wound protector.Subsequently, a massive leak occurred due to the complete detachment of the trocar's valve.The entire valve detached intact (photos attached).The component was clear/transparent.Yes, the surgeon attempted to resolve the initial leakage by packing gauze around the interface of the alexis wound protector.The insufflator pressure was set to 13 mmhg, with the flow rate set to maximum.No, a visual inspection revealed no apparent damage on the gelseal cap.Intervention: ni patient status: there is no impact to patient.

• Brand Name: GELPOINT® MINI ADVANCED ACCESS PLATFORM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 23316546
• Report Number: 2027111-2025-00809
• Device Sequence Number: 20284244
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K191866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNGL3
• Device Catalogue Number: 101473942
• Device Lot Number: 1552958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MM LAPAROSCOPE; STANDARD 5MM INSTRUMENTS
• Patient Sex: Unknown