MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GELPORT® HAND ACCESS LAPAROSCOPIC SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8XX2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscope, general & plastic surgery.Event description: [from fda report mw5179559].Situation: it was during the closing count when the scrub technician noticed that the polyurethane of the wound protector from the gelport was torn.The surgeon was informed immediately.The surgeon performed a wound check and used the endoscope to examine intraabdominally.No retained object was found.Background the gelport contains 3 pieces: the gelseal cap, the alexis o wound protector and the retention ring.The gelport was used during minimal invasive surgery for unlimited trocar insertion and instrument or hand exchanges while maintaining pneumoperitoneum.Assessment the alexis o wound protector consists of the white ring and polyurethane surround to protect the wound.During repeated instrument exchanges, the polyurethane would tear.The team followed the policy to inform the surgery.The surgeon stated that he had examined the wound and inside the abdomen and did not find any fragment of the polyurethane.The team also went above to have x-ray on the abdomen and reported no foreign objects.Recommendation huddle with team on the team regarding the potential for the wound retractor to tear and pay extra attention when performing the count.Intervention: x-ray on the abdomen and reported no foreign objects.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

• Brand Name: GELPORT® HAND ACCESS LAPAROSCOPIC SYSTEM
• 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: 23873715
• Report Number: 2027111-2025-00945
• Device Sequence Number: 5344020
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K014047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: C8XX2
• Device Catalogue Number: 700314663
• Device Lot Number: 1565995
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 08/13/2025
• 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: TROCARS
• Patient Sex: Unknown