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

Model Number	C8401
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: ni.Event description: i have been alerted by my clinical colleague (name redacted) that whilst in the operating theatre 2 of your product c8401 have broken whilst in use.(name redacted) will be able to have the appropriate team member explain the behavior of this item prior to use and whilst in use in a hope your team can work or the causation of this occurrence.The lot numbers of both used alexis ring (small) is as follows (b)(6).Additional information received from applied medical representative via email on 27jan2026: images in the attachments.I have requested the below information from the customer and have attached 2 pictures they sent to me.As soon as i can obtain any additional information i will inform you.Intervention: ni.Patient status: no patient injury reported.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided, confirming the complainant¿s experience of sheath tear.Based on the description of the event and the photos provided, it is likely that a sharp object or instrument came into contact with the sheath, resulting in holes or tears that further propagated due to the stress experienced by the sheath.The instructions for use (ifu) states, "avoid sharp instruments contacting the device, as it may damage the device or cause patient injury." applied medical has performed a historical trend analysis and review of production records and no trends were identified.
Event or Problem Description
Procedure performed: (b)(6).Event date: unknown.Event description: i have been alerted by my clinical colleague (name redacted) that whilst in the operating theatre 2 of your product c8401 have broken whilst in use.(name redacted) will be able to have the appropriate team member explain the behavior of this item prior to use and whilst in use in a hope your team can work or the causation of this occurrence.The lot numbers of both used alexis ring (small) is as follows (1550713).Additional information received from applied medical representative via email on 27jan26: images in the attachments.I have requested the below information from the customer and have attached 2 pictures they sent to me.As soon as i can obtain any additional information i will inform you.Intervention: (b)(6).Patient status: no patient injury reported.

• Brand Name: ALEXIS O 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: 24328310
• Report Number: 2027111-2026-00363
• Device Sequence Number: 9966667
• Product Code: KGW
• UDI-Device Identifier: 00607915117252
• UDI-Public: (01)00607915117252
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: C8401
• Device Catalogue Number: 101478488
• Device Lot Number: 1550713
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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