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	01/06/2025
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: endoscopic nipple sparing mastectomy.Event description: gelpoint mini was placed in a 3.5mm axillary incision.3 x 10mm trocars have been placed in the gelseal cap.After 1hour and 40 minutes of surgery, an important leakage of co2 has been identified.Looking closer to the device it appears that one trocar is leaking and that the instrument shield has been pushed into the sleeve of the trocar.The damaged trocar has been removed and replaced by the remaining 12mm trocar.Replaced the 10mm trocar by the remaining 12mm trocar.Additional information received from company rep.Via email on 08jan25: yes leak came through the trocar.The leaking occurred for 3-4 minutes.Only when instruments where in the trocar, the leak occurred.No excessive force was necessary to insert the instrument.Component separate from the seal when leaking occurred.No particulation fell into patient.Replaced trocar by the 12mm port.No slit was cut by the surgeon in the gel at any time.Intervention: replaced the 10mm trocar by the remaining 12mm trocar patient status: patient is ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of instrument shield dislodgement.Based on the condition of the returned unit, 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.
Event or Problem Description
Procedure performed: endoscopic nipple sparing mastectomy.Event description: gelpoint mini was placed in a 3.5mm axillary incision.3 x 10mm trocars have been placed in the gelseal cap.After 1hour and 40 minutes of surgery, an important leakage of co2 has been identified.Looking closer to the device it appears that one trocar is leaking and that the instrument shield has been pushed into the sleeve of the trocar.The damaged trocar has been removed and replaced by the remaining 12mm trocar.Replaced the 10mm trocar by the remaining 12mm trocar.Additional information received from company rep.Via email on 08jan25: yes leak came through the trocar.The leaking occurred for 3-4 minutes.Only when instruments where in the trocar, the leak occurred.No excessive force was necessary to insert the instrument.Component separate from the seal when leaking occurred.No particulation fell into patient.Replaced trocar by the 12mm port.No slit was cut by the surgeon in the gel at any time.Intervention: replaced the 10mm trocar by the remaining 12mm trocar.Patient status: patient is ok.

• 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: 21172482
• Report Number: 2027111-2025-00320
• Device Sequence Number: 4252158
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 1526056
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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: 10MM 30° SCOPE; 5MM GASPER; 5MM MONOPOLAR HOOK; 5MM SCISSORS; 5MM VOYANT ADVANCED BIPOLAR DEVICE; TROCAR WIPE CLEARIFY
• Patient Sex: Unknown