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Model Number ER320 |
Device Problems
Mechanical Problem (1384); Failure to Form Staple (2579)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to obtain additional information and to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent: please clarify " the jaw overlaps", was the jaw misaligned ? if other, please specify.Please provide the status of the device(s) as it has not been received for analysis.
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Event Description
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It was reported that during an unknown procedure, the clips "get out like x shape from the jaw overlaps.Surgeon used oversewing technique instead of clip applier.There was no patient consequence.
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Manufacturer Narrative
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(b)(4).Date sent: 1/15/2021.H2: additional information received: there were only two items of issue for this event (reported first device on mwr-16122020-0000862176 and second device on mwr-16122020-0000862177).There was no third device that had a quality issue.See corrected data in d11 for third device.Per additional information received (see h10), there were only two items of issue for this event (first device reported on mwr-16122020-0000862176 and second device reported on mwr-16122020-0000862177).There was no third device that had a quality issue.Upon review of this additional information provided in h10, it was concluded that as there was no third device of issue for this event, therefore event for a third device does not meet the fda defined criteria for a reportable event and is being considered not reportable/void.
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Search Alerts/Recalls
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