ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Model Number B11LT |
Device Problem
Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being 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.
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Event Description
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It was reported that prior to a laparoscopic cholecystectomy, they opened up device, and there was a piece missing, the flapper door.They opened up another device to complete the case.There was no patient contact (no patient consequence).
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Manufacturer Narrative
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(b)(4).Date sent: 10/23/2020.Investigation summary: the analysis results found that the b11lt device was returned with the scope locking cam (housed in obturator handle) missing.In addition, the tyvek was returned along with the instrument.No conclusion could be reached as to how this issue occurred.We have documented the circumstances as they were reported to us.It should be noted that as part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
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Search Alerts/Recalls
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