Catalog Number 261221 |
Device Problem
Failure to Auto Stop (2938)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/20/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
|
|
Event Description
|
It was reported that the perforator did not stop when surgeon arrived to the space between the cranial bone and dura-mater.There was no adverse event or delay in surgery.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
Udi (b)(4).The device was returned for evaluation and visually inspected utilizing unaided eye.No anomalies were observed other than a worn label.Test performed and the unit was found to performed as intended.Unit completed testing (5 holes) and was found to performed as intended.Complaint could not be verified as the unit was found to meet all acceptance criteria.A review of quality records was conducted and prior to distribution.This device met all manufacturing and quality testing/inspection specifications.
|
|
Search Alerts/Recalls
|