MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS WOUND PROTECTOR-RETRACTOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8313
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: formation of defunctioning loop colostomy.Description of event: "we had an incident last week whereby one of the xxs alexis retractors broke.Here is a brief description of event: "patient was in theatre for formation of defunctioning loop colostomy, alexis wound retractor xxs was requested by surgeon.Alexis was inserted into abdominal opening, while turning down external loop the connecting sheath split vertically between the rings." additional information received from company rep.Via email on 05jun24: - the event date initially reported was incorrect and the incident occurred on (b)(6) 2024, i was notified on 04-06-24.- the lot number is 1502196.- the device has been disposed of, but a picture of the device was taken.Intervention: unknown.Patient status: uknown.
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 of the photo confirmed the complainant¿s experience of sheath tear.It was also noted some of the torn portions contained jagged edges.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.Correction: updated the brand name in section d1.
Event or Problem Description
Procedure performed: formation of defunctioning loop colostomy.Description of event: "we had an incident last week whereby one of the xxs alexis retractors broke.Here is a brief description of event: "patient was in theatre for formation of defunctioning loop colostomy, alexis wound retractor xxs was requested by surgeon.Alexis was inserted into abdominal opening, while turning down external loop the connecting sheath split vertically between the rings." additional information received from company rep.Via email on 05jun2024: the event date initially reported was incorrect and the incident occurred on 07-05-2024, i was notified on (b)(6) 2024.The lot number is 1502196.The device has been disposed of, but a picture of the device was taken.Additional information received from company rep.Via email on 13aug2024: alexis split when folding it down before planning to bring a loop of bowel out to form stoma.Reported incident to the appropriate persons, handed faulty/damaged item off the sterile field.No particulation was noticed.Intervention: unknown.Patient status: patient is well.

• Brand Name: ALEXIS WOUND PROTECTOR-RETRACTOR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19589665
• Report Number: 2027111-2024-00708
• Device Sequence Number: 3340289
• Product Code: GCJ
• UDI-Device Identifier: 00607915125219
• UDI-Public: (01)00607915125219(17)260827(30)01(10)1502196
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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 Expiration Date: 08/27/2026
• Device Model Number: C8313
• Device Catalogue Number: 101355501
• Device Lot Number: 1502196
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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