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

Model Number	C8XX2
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na (before use).Detailed description of event: information provided by [name] on 30mar2026: i am [name].I am the urology lead in st at [facility].I have a laparoscopic hand assist port that had a hair inside.We would like to get it replaced.Additional information provided by [name] on 01apr2026: i have it with me.I can give to [name] - she will be receiving the replacement and will send this out.Additional information provided by [name] on 13apr2026: the timing of the event was right when we opened the package to the sterile field.[name] has the package which should have the lot # type of intervention: na (before use).Patient status: na (before use).

• 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: 24916847
• Report Number: 2027111-2026-00502
• Device Sequence Number: 18765625
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 1570760
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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
• Patient Sex: Unknown