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	05/15/2025
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: diagnostic laparoscopic case.Event description: from the account manager: i was notified today that a doctor was doing a diagnostic laparoscopic case with the gelpoint mini cngl3 and a piece feel out of the trocar and was found and removed from the patient with no harm.The account has keep the device with lot # 1546692 with expiration of 2028-03-05 at the hospital if needed.Please advise on next steps.Additional information obtained from account manager via email on 16may2025: this was not a robotic surgery.The leakage occurred at the sleeve.The leak did not only occur when instrumentation was placed through the trocar.It was observed that a component separated from the sleeve/trocar seal when leakage occurred.The entire component fell off and fell into the patient.The surgeon attempted to resolve the leakage and removed the sleeve.The pressure and flow were set to 40 pressure/15 flow.The were no damages to the gelseal cap.Intervention: found and removed from the patient with no harm.Patient status: no harm.
Event or Problem Description
Procedure performed: diagnostic laparoscopic case.Event description: from the account manager: i was notified today that a doctor was doing a diagnostic laparoscopic case with the gelpoint mini cngl3 and a piece feel out of the trocar and was found and removed from the patient with no harm.The account has keep the device with lot # 1546692 with expiration of 2028-03-05 at the hospital if needed.Please advise on next steps.Additional information obtained from account manager via email on 16may2025: this was not a robotic surgery.The leakage occurred at the sleeve.The leak did not only occur when instrumentation was placed through the trocar.It was observed that a component separated from the sleeve/trocar seal when leakage occurred.The entire component fell off and fell into the patient.The surgeon attempted to resolve the leakage and removed the sleeve.The pressure and flow were set to 40 pressure/15 flow.The were no damages to the gelseal cap.Intervention: found and removed from the patient with no harm.Patient status: no harm.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a dislodged shield.Based on the provided photograph and description of the event, it is likely that the reported event was caused by an instrument that was inserted or removed through the seal subassembly in a non-axial manner.The instructions for use (ifu) states, ¿all instruments should be centered axially when inserted through the sleeve¿s seal to avoid potential damage to sleeve." applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.

• 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: 22066928
• Report Number: 2027111-2025-00541
• Device Sequence Number: 9394433
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/08/2025

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: 1546692
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: ENERGY DEVICE.; FLEXIBLE SCOPES.; LAPAROSCOPIC GRASPERS.; TROCAR.
• Patient Sex: Unknown