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	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: c-section.Event description: [hospital], model #: g6313, lot #: 1516917.The device ripped.They did not replace with a new alexis, and metal retractors were used to complete the procedure.No harm to patient.The device will not be returning and was discarded.Please refer to attachments for photos.Intervention: metal retractors were used.Patient status: no harm to patient.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided.Visual inspection confirmed the complainant¿s experience of sheath tear.Based on the description of the event and the photo provided, it is likely that a sharp object or instrument came into contact with the sheath, resulting in a hole or tear that further propagated during use.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: c-section.Event description: [hospital], model #: g6313, lot #: 1516917.The device ripped.They did not replace with a new alexis, and metal retractors were used to complete the procedure.No harm to patient.The device will not be returning and was discarded.Intervention: metal retractors were used.Patient status: no harm to patient.

• 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: 21368585
• Report Number: 2027111-2025-00358
• Device Sequence Number: 8519316
• Product Code: KNA
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: G6313
• Device Catalogue Number: 101475823
• Device Lot Number: 1516917
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2024
• 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
• Patient Sex: Unknown