Catalog Number B5LT |
Device Problems
Melted (1385); Dent in Material (2526)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date of event: only event year known: 2019.Batch # unknown.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
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Event Description
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It was reported that during a laparoscopy the metal on the obturator was dented and the plastic tip of the obturator was melted or misshapen.A trocar from a different lot was used to complete the procedure.There were no patient consequences reported.
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Manufacturer Narrative
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(b)(4) device analysis: the analysis results found that the b5lt device was returned with the obturator cannula damaged bent and with the clear lens melted.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device batch t92z88 number, and no non-conformance were identified.
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Search Alerts/Recalls
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