Model Number 176613 |
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 08/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A good faith effort will be made to obtain the applicable information relevant to the report.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: occurred during a laparoscopic nephrectomy.There was something black noticed inside the patient.The surgeon removed the foreign material, which was a component of the retracting tool being used.The device was examined to ensure that all disengaged components were removed from the patient.No known impact or consequence to patient.
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Manufacturer Narrative
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Section evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the clevis pieces was broken and on both sides of the instrument.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur as a result of the instrument being forced beyond it indicated use.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.A relationship between the device and the reported incident of broken clevis was confirmed.A review of the current complaint data reveals no trend for a device related failure for this condition.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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