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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
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.Description of event: [hospital] product: c8401.During the case, the doctor tried rolling the alexis only once rolling then the retraction ring(white) was broken.No product returning.Intervention: ni.Patient status: no patient injury.
Event or Problem Description
Procedure performed: colectomy.Description of event: [hospital].Product: c8401.During the case, the doctor tried rolling the alexis only once rolling then the retraction ring(white) was broken.No product returning.Intervention: ni.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformance's that could have contributed to the reported event.Based on the description of the event it is possible that the reported event unit was manufactured with damages or non-conformance's on the device and falsely passed manual inspection.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 20080817
• Report Number: 2027111-2024-00803
• Device Sequence Number: 15350983
• Product Code: KGW
• UDI-Device Identifier: 00607915117252
• UDI-Public: (01)00607915117252
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 06/05/2025
• Device Model Number: C8401
• Device Catalogue Number: 100938801
• Device Lot Number: 1456661
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 12/05/2024
• Date Device Manufactured: 06/06/2022
• 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