Model Number 909075 |
Device Problem
Sparking (2595)
|
Patient Problem
No Code Available (3191)
|
Event Date 05/24/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Coopersurgical inc.Is currently investigation the reported complaint condition.The device involved in the complaint was returned by the customer and evaluated.Once the investigation is completed a follow up report will be filed.Reference (b)(4).
|
|
Event Description
|
Reference (b)(4).Review of service and repair log # 85902."machine was set for cut 50 watt.Patient grounded before machine turned on.Md was not near the foot pedal- pen was down.Vacuum started running a spark hit patient's thigh.".
|
|
Manufacturer Narrative
|
Coopersurgical inc.Is currently investigation the reported complaint condition.The device involved in the complaint was returned by the customer and evaluated.Once the investigation is completed a follow up report will be filed.Reference e-complaint: (b)(4).Investigation: inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals no similar issues.A review of the dhr is not available but not expected to provide relevant information for this complaint.Based on the s/n, this unit was manufactured before 2000.Service & repair was not able to duplicate the complaint condition.The unit was evaluated and tested but no failures were detected.Although this unit is over a decade old the check on the unit demonstrated a fully functional unit.There is no definitive root cause for this complaint condition.It is possible there was some end user error or certain conditions were present during the customer's observation(s).Correction and/or corrective action: the unit was evaluated at a charge and returned to the customer.This complaint will be entered into the coopersurgical continuous improvement plan (cip).Reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.Was the complaint confirmed? no.
|
|
Event Description
|
Reference e-complaint: (b)(4).Review of service and repair log # 85902."machine was set for cut 50 watt.Patient grounded before machine turned on.Md was not near the foot pedal- pen was down.Vacuum started running a spark hit patient's thigh.".
|
|
Search Alerts/Recalls
|