PERLA TL
Received Jul 22, 2026 · Event occurred Jul 15, 2026
Report 3007728266-2026-00021 · MDR key 25904425
Device
Product problems
- Material Disintegration
Patient
NA · Unknown
- Needle Stick/Puncture
Narrative
Description of Event or Problem
WE RECEIVED A COMPLAINT FROM SINGAPORE ON (B)(6) 2026 (REGISTERED UNDER CPT-4754) REPORTING THAT THE IN/OUT SET SCREW HAS A THREAD THAT CAME OFF FROM THE SET SCREW AND CUT THE NURSE AND PIERCED THROUGH HER GLOVES. THE SURGEON TIGHTEN THE SET SCREWS AND LOOSEN IT AGAIN, WHEN IT WAS PASSED BACK TO THE NURSE THE THREAD JUST CUT THROUGH THE NURSE'S GLOVES AND CUT HER FINGER. WE REPORT THE CASE TO THE FDA BECAUSE THIS PRODUCT IS MARKETED IN THE US.
Additional Manufacturer Narrative
THE CAPA "CAPA-2026-0014" HAS BEEN OPENED TO IDENTIFY THE ROOT CAUSE AND IMPLEMENT THE NECESSARY ACTIONS. ESTIMATED TIMELINE TO IDENTIFY THE ROOT CAUSE IS (B)(6) 2026.