MalfunctionGEI
DEPUY MITEK VAPR 90
Received Jun 25, 2020 · Event occurred Jun 18, 2020
Report MW5095239 · MDR key 10200476
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Product code (GEI)
Manufacturer (Medline Renewal)
Model (OEM 225370)
Device
Generic name
Electrosurgical, Cutting & Coagulation & Accessories
Manufacturer
Medline RenewalCatalog number
OEM 225370
Lot number
MEDLINE RENEWAL 430234
Product problems
- Break
- Detachment of Device or Device Component
Patient
41 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
VERY SMALL PIECE OF "THE GRATE" ON THE TIP OF A REPROCESSED MITEK VAPR 90 BROKE OFF WHILE THE SURGEON WAS WORKING. REPROCESSING COMPANY NOTIFIED AND INSTRUMENT WAS SENT OUT FOR INSPECTION/QUALITY CONTROL CHECK. FDA SAFETY REPORT ID# (B)(4).