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Model Number EL5ML |
Device Problem
Failure to Form Staple (2579)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch #: unknown.Date of event is 2020.Event day and event month were not reported.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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 clip didnt formation" did device fire unformed or malformed clips? did device fire scissored clips? if other, please clarify were there any patient consequences? if yes, please describe.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 clip didn't "formation." the surgery was not delayed due to the reported event.It is unknown how procedure was completed.Patient consequence was not reported.
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Manufacturer Narrative
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(b)(4) date sent: 2/9/2021 d4: batch # u93k4y investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the el5ml device was returned with no apparent damage.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed eight conforming clips.The event described could not be confirmed as the device performed without any difficulties noted.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following: "caution: do not excessively twist or torque the instrument jaws when positioning or firing the instrument on a tubular structure or vessel.Excessive twisting or torquing may result in clip malformation." as part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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Search Alerts/Recalls
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