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	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap bso.Event description: the surgeon was trying to introduce an instrument through one of the trocars when they heard a pop sound and upon investigation it was apparent that the whole instrument guard from one of the trocars had been detached from the trocar.It was fully intact, so the surgeon continued and finished the case.They had used 2 retrieval bags on sticks through the trocar prior to the incident.Intervention: ni.Patient status: recovering post operation.
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
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-conformances that could have contributed to the reported event.Based on the 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 sleeves 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.
Event or Problem Description
Procedure performed: lap bso.Event description: the surgeon was trying to introduce an instrument through one of the trocars when they heard a pop sound and upon investigation it was apparent that the whole instrument guard from one of the trocars had been detached from the trocar.It was fully intact, so the surgeon continued and finished the case.They had used 2 retrieval bags on sticks through the trocar prior to the incident.Additional information received from applied medical representative via email on 29may2025: they had been using a retrieval bag through the trocar prior to the instrument guard detaching, but the trocar stayed in the gelseal cap.They were using a grasper throw the trocar when they heard a ¿pop¿ sound and removed the gelseal cap to find the instrument guard around the shaft of the grasper.No particulation, it detached as a whole piece.Unfortunately, no image, i asked them to keep the trocar, but they automatically throw the trocars into the sharps bin at the end of the case, before i was able to get a photo.Intervention: continued to use with the trocar without instrument guard as it was very close to end of case.Patient status: recovering post operation.Recovering from surgery well, no adverse effect.

• 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: 22110807
• Report Number: 2027111-2025-00559
• Device Sequence Number: 4171436
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• 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: 1530185
• Was Device Available for Evaluation?: No
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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: 2 RETRIEVAL BAGS ON STICKS
• Patient Sex: Unknown