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	10/16/2024
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: reduce port surgery event description: gelpoint was placed into a 2.5cm incision at the umbilicus for specimen extraction and for reduce port surgery.The camera was placed through a 10mm sleeve and a separate 10mm sleeve was placed through the gel for the assist port.When the surgeon finished morcellating the specimen he recapped the gelpoint to take a final look in the abdomen and noticed the clear plastic piece that comes inside the sleeve had detached and was laying on top of the patient's bowel.Had he not taken a final look, the plastic piece could have been left in the patient's abdomen.No additional product needed to be pulled since it was noticed at the end of the procedure.Type of intervention: no additional product needed to be pulled since it was noticed at the end of the procedure.Patient status: no patient injury.
Event or Problem Description
Procedure performed: reduce port surgery.Event description: gelpoint was placed into a 2.5cm incision at the umbilicus for specimen extraction and for reduce port surgery.The camera was placed through a 10mm sleeve and a separate 10mm sleeve was placed through the gel for the assist port.When the surgeon finished morcellating the specimen he recapped the gelpoint to take a final look in the abdomen and noticed the clear plastic piece that comes inside the sleeve had detached and was laying on top of the patient's bowel.Had he not taken a final look, the plastic piece could have been left in the patient's abdomen.No additional product needed to be pulled since it was noticed at the end of the procedure.Type of intervention: no additional product needed to be pulled since it was noticed at the end of the procedure.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the shield was separated from the sleeve.Based on the condition of the returned unit, it is likely that the reported event was caused by an asymmetrical instrument that was inserted through the sleeve in a non-axial manner.The instructions for use (ifu) states, ¿all instruments should be centered axially when inserted through the sleeve¿s seal for easier insertion." 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: 20604575
• Report Number: 2027111-2024-00893
• Device Sequence Number: 15436005
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 1527340
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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: CAMERA; SLEEVES
• Patient Sex: Unknown