MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS LAPAROSCOPIC SYSTEM; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8502
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: anterior resection.Event description: "it was torn." product is available for return.Additional information was received via email on 07apr2026 from [name], amk territory manager."it's unknown during what step in the procedure the malfunction occurred.It's unknown where the sheath separated/tore from.It's impossible to provide the pictures.It's unknown whether any instruments were used within the alexis during placement.It's unknown whether any instruments were used within the alexis during the procedure.It's unknown whether it particulated." intervention: ni.Patient status: there was no problem with the patient.
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

• Brand Name: ALEXIS LAPAROSCOPIC SYSTEM
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• 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: 25035360
• Report Number: 2027111-2026-00527
• Device Sequence Number: 13327289
• Product Code: KGW
• UDI-Device Identifier: 00607915119935
• UDI-Public: (01)00607915119935
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: C8502
• Device Catalogue Number: 101357101
• Device Lot Number: 1563913
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 07/30/2025
• 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