Catalog Number 89-8507-400-10 |
Device Problems
Complete Blockage (1094); Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Failure to Auto Stop (2938)
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Patient Problem
No Information (3190)
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Event Date 11/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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Complaint number (b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be sent if the product is returned or if additional information is received.
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Event Description
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It was reported that the universal modular electric/battery single trigger handpiece part number 89-8507-400-10 serial number (b)(4) does not stop, the trigger is blocked.The event occurred during surgery.An extension of surgery of 60 minutes was reported due to the time needed to replace the device.There was no additional harm or injury to patient/operator reported.
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Manufacturer Narrative
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(b)(4).Universal modular electric/battery single trigger handpiece, part number: 89-8507-400-10, serial number: (b)(6), was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the device was starting itself due to a blocked trigger.Moreover, the controller board wires were damaged and the motor was noisy.No repair was performed due to rejected quotation from the customer.Device was sent back to customer unrepaired with a discharge letter.
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Event Description
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It was reported that the universal modular electric/battery single trigger handpiece part number: 89-8507-400-10, serial number: (b)(6) was running on its own and the trigger was stuck.The event occurred during surgery.An extension of surgery of 60 minutes was reported due to the time needed to replace the device.The patient was under anesthesia at the time of the delay.There was no additional harm or injury to patient/operator reported.
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Search Alerts/Recalls
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