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

Model Number	C8301
Medical Device Problem Codes	No Apparent Adverse Event (3189); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lobectomy event description: toward the end of the procedure, when the surgical team removed the wound protector to retrieve the specimen, a tear was observed between the white ring and the wound sheath.Additional information obtained from distributor via email on 11jun2025: no instruments used within the alexis during placement.Grasper and scope were used during the procedure.The device did not particulate, and particulate did not fall into the patient.Intervention: user replace with a new one.Patient status: the patient is in good condition.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided upon the completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant¿s experience of gaps between the outer ring and the sheath.Based on the condition of the returned unit, it was confirmed that the observed gaps between the outer ring and the sheath are an intentional design feature.The event unit met current specifications and there were no visible non-conformances.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: lobectomy.Event description: toward the end of the procedure, when the surgical team removed the wound protector to retrieve the specimen, a tear was observed between the white ring and the wound sheath.Additional information obtained from distributor via email on 11jun2025: no instruments used within the alexis during placement.Grasper and scope were used during the procedure.The device did not particulate, and particulate did not fall into the patient.Intervention: user replace with a new one.Patient status: the patient is in good condition.

• Brand Name: ALEXIS WOUND PROTECTOR-RETRACTOR
• 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: 22475734
• Report Number: 2027111-2025-00634
• Device Sequence Number: 18188927
• Product Code: KGW
• UDI-Device Identifier: 00607915117207
• UDI-Public: (01)00607915117207
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: C8301
• Device Catalogue Number: 101478494
• Device Lot Number: 1543574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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: GRASPER & SCOPE
• Patient Sex: Unknown