MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS O C-SECTION PROTECTOR - RETRACTOR; INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Model Number	G6313
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: open myomectomy.Event description: account manager was present during the procedure.During the procedure, the surgeon and nurse both noticed that the polyurethane at the bottom of the unit was ripped.They removed the ripped device and completed the surgery with a second unit.Photo will be provided.Additional information provided by [name] on 06feb2026 via email: open myomectomy.No other disposables, blunt instrumentation only.Separated from the film itself.No other instruments used during insertion.During the procedure, richardson retractor and various clamps, cautery but it remained in its protective holder unless active in the surgeons hand, none used on the alexis retractor.As for particulation - not that was visible or identified.Immediately upon the visualization of the separation of the film of the alexis, it was removed and replaced with a new alexis retractor.Intervention: used another unit to complete the surgery.Patient status: no patient injury.
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: ALEXIS O C-SECTION PROTECTOR - RETRACTOR
• Common Device Name: INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• 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: 24531998
• Report Number: 2027111-2026-00424
• Device Sequence Number: 10372203
• Product Code: KNA
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K062907
• 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): 05/15/2026

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: G6313
• Device Catalogue Number: 101478551
• Device Lot Number: 1563925
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2025
• 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: RICHARDSON RETRACTOR; VARIOUS CLAMPS, CAUTERY
• Patient Sex: Unknown