|
Catalog Number EMAX2PLUS |
Device Problem
Device Alarm System (1012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/18/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during an unspecified surgical procedure, it was observed that the motor device was overheating and giving an e6 error code.It was not reported that there was a ten minute delay in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi:(b)(4).
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: h6: device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no non-conformances or abnormalities identified during the manufacture of the device that may have contributed to the reported condition.Correction: d4: unique identifier(udi) number: the udi number was inadvertently recorded as (b)(4) in the initial medwatch report.The udi number has been updated to (b)(4).
|
|
Search Alerts/Recalls
|
|
|