MalfunctionFFO
SKLAR®
Received Apr 9, 2025 · Event occurred Apr 3, 2025
Report 21804614 · MDR key 21804614
Device
Generic name
Retractor, Self-retaining
Manufacturer
Sklar CorporationModel number
42-1631Catalog number
42-1631
Product problems
- Material Deformation
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
BRAND NEW SURGICAL INSTRUMENTS, PURCHASED AND UNPACKAGED, INSPECTED PRIOR TO PROCESSING THROUGH THE SPD [STERILE PROCESSING DEPARTMENT] DEPARTMENT, PITTING NOTED ON 2 OF THE 20 ITEMS PURCHASED; INSTRUMENT NOTED WITH PITTING IS A NORFOLK-NORWICH RETRACTOR FROM SKLAR.