MalfunctionDWH
UNIVERSAL HOSE, 10'
Received Mar 13, 2009
Report 1017294-2009-00039 · MDR key 1347151
Device
Generic name
Surgical Instrument Motor Access/attachment
Manufacturer
Conmed LinvatecModel number
NACatalog number
00505201000
Lot number
NK
Product problems
- Explode
Patient
Not reported
- Treatment with medication(s)
Narrative
Additional Manufacturer Narrative
INVESTIGATION RESULTS: AN EVALUATION OF THE RETURNED HOSE FOUND THE OUTER HOSE HAD RUPTURED AT THE COUPLING END. FURTHER EXAMINATION FOUND THE DIFFUSER END DAMAGED (OUT OF ROUND) AND EVIDENCE OF THIRD PARTY REPAIR. USER MEDWATCH RECEIVED FROM FDA ON FEBRUARY 23, 2009. THIS EVENT IS BEING REPORTED BECAUSE THE HOSE WAS ASSOCIATED WITH A FAILURE WHICH RESULTED IN MEDICAL INTERVENTION (ANTIBIOTICS GIVEN).