Model Number T.W. POWER SUPPLY |
Device Problem
Failure to Deliver Energy (1211)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/24/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
|
|
Event Description
|
The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply shut off in the middle of a case, would not cauterize.Procedure completed with new device.No patient effects.
|
|
Manufacturer Narrative
|
Trackwise # (b)(4).Analysis of production: (3331/213/67/3221) the reported device is an oem device.The certificate of conformance was reviewed for the reported serial/lot number.The vendor certifies that this device serial conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.Historical data analysis: (4109/213/67/3221) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67/3221) the overall 24 month product complaint trend data for the period jun 2019 through may 2021 was reviewed.There were no triggers identified for the review period.
|
|
Search Alerts/Recalls
|