MalfunctionMIJ
TUFLEX
Received Jan 29, 2021 · Event occurred Dec 29, 2020
Report 3016567401-2021-00001 · MDR key 11250305
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Product code (MIJ)
Manufacturer (Somatex Medical Technologies Gmbh)
Model (271641)
Device
Generic name
Tuflex
Manufacturer
Somatex Medical Technologies GmbhModel number
271641Catalog number
271641
Lot number
51269
Product problems
- Break
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DURING THE REMOVAL OF A SUSPECTED BREAST LESION THE MARKING WIRE TUFLEX WAS TAPPED WITH A CAUTERY DEVICE (BOVIE) AND IT SPLINTERED.