|
Model Number LP-20-120 |
Device Problem
Temperature Problem (3022)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 08/09/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Coopersurgical , inc.Is currently investigating the reported conditon.
|
|
Event Description
|
Customer stated-the loop does not heat enough to burn/cut.Customer verified-r9 and r14 burnt, r8 and c14 update done, ac cord not grounded ro 96832 1216677-2021-00209 leep precision generator lp-20-120 e-(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 01/13/2020 under wo #'s (b)(4) and shipped on 02/27/2020.Manufacturing record review: dhr's (b)(4) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log 96832.Visual evaluation: visual examination of the complaint unit revealed no physical damage.However, once opened, the internal damage to the display board components, r9 & r14 was noted.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause : an initial investigation by technical operations (csi's engineering dept.) has indicated resistors r9 and r14 were burnt out due to being exposed to current outside their rating.The root cause of this issue has been attributed to under rated resistors.*correction and/or corrective action the units' board was updated to the latest revision, tested to specifications and returned to the customer.The resisters were updated to a higher rating on the boards via (b)(4).A redline was provided to the board vendor to produce boards in their wip to include the new resistors and csi inventory was re-worked (wo #(b)(4)) to have the resistors replaced.Ref capa 731.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
|
|
Event Description
|
Customer stated-the loop does not heat enough to burn/cut.Customer verified-r9 and r14 burnt, r8 and c14 update done, ac cord not grounded ro (b)(4).1216677-2021-00209 leep precision generator lp-20-120 e-complaint-(b)(4).
|
|
Search Alerts/Recalls
|
|
|