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Catalog Number 26-1221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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As reported by an customer, the perforator did not function as intended during use on 2 burr holes.On the first burr hole, the perforator failed to disengage; however, there are no reports of injury to the patient.On the second burr hole, the perforator prematurely disengaged.There were no reports of delay.
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Manufacturer Narrative
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(b)(4).It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
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Search Alerts/Recalls
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