Model Number 909075 |
Device Problem
Sparking (2595)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/11/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Coopersurgical , inc.Is currently investigating the reported condition.
|
|
Event Description
|
Customer stated "excessive sparking during use.R/f leakage error flashing.Coag led out." repair tech stated "confirmed complaint: bad front panel pc and main pc." reference repair order (b)(4).E-complaint-(b)(4).1216677-2020-00232 quantum2000 electrosurg 909075 e-complaint-(b)(4).
|
|
Event Description
|
Customer stated "excessive sparking during use.R/f leakage error flashing.Coag led out." repair tech stated "confirmed complaint: bad front panel pc and main pc." reference repair order (b)(4).E-complaint (b)(4).1216677-2020-00232.Quantum2000 electrosurg 909075 e-complaint (b)(4).
|
|
Manufacturer Narrative
|
Investigation x-review dhr.X-inspect returned samples.*analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 8/27/2015 under wo#'s (b)(4) and shipped on 9/22/2015.Manufacturing record review: dhr va0215 & 188082 were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: this unit was returned in 2018 & 2019 for an unconfirmed complaint and an update last year in april.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.The complaint was not confirmed.Product receipt: the complaint unit was returned on repair log 94934.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint units' display board was no longer functioning.Root cause: no definitive root cause for this issue could be reliably determined at this time.Correction and/or corrective action.The customer requested the unit be returned to them "as-is".As such, no additional information on the unit was possible.The customer was made aware this model is discontinued and replaced by the leep precision system.No further corrective action is necessary.No further training required at this time.Preventative action activity.Coopersurgical will continue to monitor this complaint condition for trends.
|
|
Search Alerts/Recalls
|