MalfunctionGDG
DURAHOOK 1/4" HOOK
Received Mar 30, 2011 · Event occurred Sep 3, 2010
Report 3003898360-2011-00147 · MDR key 2068079
Device
Generic name
Elastic Retractor
Manufacturer
Teleflex MedicalModel number
NACatalog number
382800
Lot number
01H0900257
Product problems
- Degraded
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: THE BANDS ARE FALLING APART. NO PT INJURY REPORTED.
Additional Manufacturer Narrative
EVAL: DEVICE HISTORY RECORD REVIEW. RESULTS: VISUAL EXAMINATION CONFIRMED THAT THE BANDS WERE DETERIORATED/BROKEN. DEVICE HISTORY REVIEW SHOWED NO SIMILAR DEFECT REPORTED DURING THE MFG OR PACKAGING OF THIS LOT NUMBER. CONCLUSIONS: (B)(4) WAS IMPLEMENTED TO ADDRESS THE ISSUE. THE DEVICE WAS MANUFACTURED PRIOR TO CORRECTIVE ACTION.
Remedial action
- Other