Catalog Number 89-8507-400-00 |
Device Problems
Partial Blockage (1065); Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device was not yet returned to the manufacturer at the date of this report.A follow up medwatch will be submitted once the investigation is completed or if additional information is received.
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Event Description
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It was reported that the modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(4) was blocked and not functional.During the total hip replacement surgery, a delay of 65 mins was reported as device was replaced for another one to finish the surgery.Due to this delay more anesthesia had to be applied to the patient.No other harm or injury was reported to patient/operator.
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Manufacturer Narrative
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Universal modular electric/battery double trigger handpiece serial number (b)(4) was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the motor was noisy, the wire connecting the trigger board to controller board as well as the locking system between the attachment and the handpiece were defective.The event reported by the customer (bloqued & not functional) was confirmed.Following the instructions of the customer, the device was returned unrepaired with a discharge letter.
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Search Alerts/Recalls
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