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	10/20/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: colectomy.Event description: ai translated: incident which occurred on (b)(6) 2024 concerning an alexis retractor with commercial reference g6313 and batch number 1525898 from the applied medical france laboratory.Use of an alexis retractor which split when during use for a colectomy, which was noticed by the team during washing.No clinical consequences for the patient.This is not a recurring problem.Intervention: they noticed it at the end of the procedure so they did not replace it.Patient status: no clinical consequences for the patient.
Event or Problem Description
Procedure performed: colectomy.Event description: ai translated: incident which occurred on (b)(6) 2024 concerning an alexis retractor with commercial reference (b)(4) and batch number.1525898 from the applied medical france laboratory.Use of an alexis retractor which split when during use for a colectomy, which was noticed by the team during washing.No clinical consequences for the patient.This is not a recurring problem.Additional information received from company rep.Via email on 26feb25: it was at the end of the procedure.They did not use another device at this moment.It did not particulate.We could not see where it was broken.It's in a bag.Intervention: they noticed it at the end of the procedure so they did not replace it.Patient status: no clinical consequences for the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of sheath tear.Based on the condition of the returned unit and the description of the event, it is likely that a sharp object or instrument came into contact with the sheath, resulting in a hole or tear that further propagated due to the stress experienced by the sheath.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• 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: 21234925
• Report Number: 2027111-2025-00330
• Device Sequence Number: 18161647
• Product Code: KNA
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 101478493
• Device Lot Number: 1525898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown