MalfunctionFER
THD DISPOSABLE STERILE AND NOT STERIE ANO-, PROCTO- RECTOSCOPES AND LIGHT-SCOPE
Received Oct 16, 2020 · Event occurred Mar 23, 2020
Report 10689497 · MDR key 10689497
Device
Product problems
- Material Perforation
- Contamination /Decontamination Problem
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE PEEL PACK HAS PERFORATION IN IT- COMPROMISED STERILITY. 3 EACH FOUND WHILE PULLING SUPPLIES FOR CASE. MANUFACTURER RESPONSE FOR LIGHT SCOPE RECTO MAX 25CM, (BRAND NOT PROVIDED) (PER SITE REPORTER). TOLD TO DISCARD OF PRODUCT AND THEY ARE SENDING NO CHARGE REPLACEMENTS.