Model Number 174317 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a prostatectomy, the jaws of the device were broke and fell on the patient¿s cavity.They were able to retrieve the broken pieces of the device from the patient.There was no patient injury.
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Manufacturer Narrative
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Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of one device.One jaw of the device was broken after the fulcrum.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur when the device is exposed to a side force (leverage) that consequently breaks one side of the jaws.Another possibility is when the device is activated with too much force to the jaws and is used in a twisting motion resulting in breakage.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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