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

Model Number	CNGL3
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: myomectomy and lysis of adhesions event description: during surgery they found a piece in the peritoneum that appeared to be a part of the seal housing.They were able to retrieve the piece from the body.On the actual trocar that comes with the cngl3 there is a black rubber duckbill seal and a clear piece that is either before or behind that seal that looks like it has come out.Additional information provided by [company representative] on 11jun2025: the trocar/sleeve dislodged from the gel 3 hours into the case.It is unknown whether the surgeon re-inserted the trocar in a new position of the gelseal cap.Nothing reported on the trocar slipping.Nothing reported regarding the trocar slipping out of the gelseal cap during torquing/movement of instrumentation.Nothing reported on any angled instrumentation used.The product is still at [user facility] and should be shipped out this week once [initial reporter] will release product.Intervention: artifact or piece was taken out through cngl3 patient status: patient was not injured, case completed.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of shield dislodgment.The clear component was identified to be the shield, an internal plastic component of the seal.Engineering also observed the alexis sheath was torn.Based on the condition of the returned unit, it is likely that the shield dislodgment was caused by instrumentation inserted through the sleeve in a non-axial manner.The instructions for use (ifu) of the event unit states: ¿all instruments should be centered axially when inserted through the sleeve¿s seal to avoid potential damage to sleeve.¿ additionally, based on the condition of the returned unit, it is likely that a sharp object or instrument came in contact with the sheath, resulting in a hole or tear that further propagated due to the stress experienced by the sheath.The instructions for use (ifu) states "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: myomectomy and lysis of adhesions.Event description: during surgery they found a piece in the peritoneum that appeared to be a part of the seal housing.They were able to retrieve the piece from the body.On the actual trocar that comes with the cngl3 there is a black rubber duckbill seal and a clear piece that is either before or behind that seal that looks like it has come out.Additional information provided by [company representative] on 11jun2025: the trocar/sleeve dislodged from the gel 3 hours into the case.It is unknown whether the surgeon re-inserted the trocar in a new position of the gelseal cap.Nothing reported on the trocar slipping.Nothing reported regarding the trocar slipping out of the gelseal cap during torquing/movement of instrumentation.Nothing reported on any angled instrumentation used.The product is still at [user facility] and should be shipped out this week once [initial reporter] will release product.Intervention: artifact or piece was taken out through cngl3.Patient status: patient was not injured, case completed.

• 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: 22214137
• Report Number: 2027111-2025-00595
• Device Sequence Number: 12911954
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 1538980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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: SCOPE, GRASPERS, SCISSORS.
• Patient Sex: Unknown