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)
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.This report is a follow-up to medwatch # (b)(4).
Event or Problem Description
Procedure performed: ilesotomy reversal.Event description: mini gelport, 1 trocar had plastic part come off inside of patient.Ilesotomy reversal, small bowel resection, parastomal hernia repair, complex robotic assisted ventral hernia repair with mesh placement, extensive lysis of adhesions.Device failed (e.G.Broke, couldn't get it to work or stopped working) event date: november 2024.Additional information provided by (b)(6) on 20dec2024 via email (entered by (b)(6)): no patient injury occurred.The patient was discharged from the hospital.Defective device was removed from the surgical field as an intervention.The product is available for return.Yes, this was a robotic surgery.No credit or replacement is needed.An airseal insufflator was used during the surgery.Yes, a component separated from the sleeve/trocar seal.An entire component fell out.The color was clear.It fell into the patient but was retrieved.Intervention: defective device was removed from the surgical field patient status: no patient injury.
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: ileostomy reversal event description: medical device report (mdr) (b)(4).Mini gelport, 1 trocar had plastic part come off inside of patient.Ileostomy reversal, small bowel resection, parastomal hernia repair, complex robotic assisted ventral hernia repair with mesh placement, extensive lysis of adhesions.Device failed (e.G.Broke, couldn't get it to work or stopped working) event date: november 2024 additional information provided by [name] on 20dec2024 via email: no patient injury occurred.The patient was discharged from the hospital.Defective device was removed from the surgical field as an intervention.The product is available for return.Yes, this was a robotic surgery.No credit or replacement is needed.An [company name] insufflator was used during the surgery.Yes, a component separated from the sleeve/trocar seal.An entire component fell out.The color was clear.It fell into the patient but was retrieved.Intervention: defective device was removed from the surgical field.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection was performed on the event unit, which confirmed complainant¿s experience of a dislodged shield.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 for easier insertion¿ in order 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.This report is a follow-up to medwatch # (b)(4).
Event or Problem Description
Procedure performed: ilesotomy reversal.Event description: mini gelport, 1 trocar had plastic part come off inside of patient.Ilesotomy reversal, small bowel resection, parastomal hernia repair, complex robotic assisted ventral hernia repair with mesh placement, extensive lysis of adhesions.Device failed (e.G.Broke, couldn't get it to work or stopped working) event date: november 2024.Additional information provided by [name] on 20dec2024 via email: no patient injury occurred.The patient was discharged from the hospital.Defective device was removed from the surgical field as an intervention.The product is available for return.Yes, this was a robotic surgery.No credit or replacement is needed.An airseal insufflator was used during the surgery.Yes, a component separated from the sleeve/trocar seal.An entire component fell out.The color was clear.It fell into the patient but was retrieved.Intervention: defective device was removed from the surgical field.Patient status: no patient injury.

• 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: 21044660
• Report Number: 2027111-2024-00972
• Device Sequence Number: 8409667
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 1519007
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/19/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic
• Patient Race: White