MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS LAPAROSCOPIC SYSTEM; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8501
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure being performed: ni (before use).Detailed description of event: upon opening package during surgery prep, the nurse found a hair inside the packaging.Additional information provided by [name] on 20feb2026 via email: thank you for the help, i have taken photos and attached as asked.If there is anything i can do to help, just let me know.Type of intervention: ni (before use).Patient status: ni (before use).
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon the completion of the investigation.

• Brand Name: ALEXIS LAPAROSCOPIC SYSTEM
• 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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 24515492
• Report Number: 2027111-2026-00414
• Device Sequence Number: 21268849
• Product Code: KGW
• UDI-Device Identifier: 00607915119928
• UDI-Public: (01)00607915119928
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: C8501
• Device Catalogue Number: 101042501
• Device Lot Number: 1545020
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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
• Patient Sex: Unknown