ALEXIS LAPAROSCOPIC SYSTEM
Received Mar 5, 2026 · Event occurred Feb 19, 2026
Report 2027111-2026-00414 · MDR key 24515492
Device
Generic name
Ring (wound Protector), Drape Retention, Internal
Manufacturer
Applied Medical ResourcesModel number
C8501Catalog number
101042501
Lot number
1545020
Product problems
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.