NEURO-SP-1/2X1/2"-STRL 20/CS
Received Feb 6, 2026 · Event occurred Feb 2, 2026
Report 1060680-2026-00004 · MDR key 24276641
Device
Generic name
Gauze/sponge, Internal
Manufacturer
Medsorb Dominicana, S.a.Model number
30-054Lot number
24102694
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED, "PORTION OF PATTY STRING WAS DETACHED FROM THE PATTY HEAD - STRING WAS SUCTIONED AND HAD TO BE RETRIEVED. COMPLETE PARTS OF PATTY WAS ACCOUNTED FOR DURING COUNTS."
Additional Manufacturer Narrative
A USER FACILITY REPORTED, "PORTION OF PATTY STRING WAS DETACHED FROM THE PATTY HEAD - STRING WAS SUCTIONED AND HAD TO BE RETRIEVED. COMPLETE PARTS OF PATTY WAS ACCOUNTED FOR DURING COUNTS." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS NOTED THAT IT WAS UNAVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER, (B)(4). THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.