DEPUY SYNTHES PRODUCTS LLC LARGE CRANIOTOME, BLACK MAX; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME
|
Back to Search Results |
|
Catalog Number B-GOLD |
Device Problems
Fluid/Blood Leak (1250); Overheating of Device (1437)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/05/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.Concomitant products: handpiece device, craniotome device, attachment devices, compact speed reducer device.(b)(6).The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.
|
|
Event Description
|
This is report 1 of 8 for the same event.It was reported from (b)(6) that the motor device was generating heat and leaking oil while in use with a compact speed reducer device, two craniotome devices, and four attachment devices.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.The date returned to manufacturer was documented as (b)(4) 2018 on the initial report.This date has been updated to (b)(4) 2018.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the temperature of the craniotome device was above specification.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use over time.A review of the device history was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
Additional narrative: it was reported in the initial report that the date returned to manufacturer was september 7, 2018.It was inadvertently reported in the supplemental report that the date returned to manufacturer had been changed to september 6, 2018.Please note that the correct date returned to manufacturer is september 7, 2018, as was originally reported on the initial medwatch report.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|