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Model Number MCM20 |
Device Problems
Mechanics Altered (2984); No Apparent Adverse Event (3189); Firing Problem (4011)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2020 |
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 obtain additional information and to retrieve the device.To date, the device has not been returned and no additional information received.If the device or further details are received at a later date a supplemental medwatch will be sent: what is meant by clip trigger issue? did clip cut or tear artery? if so was that clip malformed? or was that clip scissored? or did the device jaws cut or tear artery? how much bleeding occurred? did new device control the bleeding? or were blood products administered? if blood products were administered, now many units of blood were administered? was there any change to the procedure? was there any change to the post-op care of the patient? was there any patient consequence? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that during a surgery of the submandibular gland by cervicofacial approach, a clip trigger issue occurred, which resulted in tearing in the artery.There was more bleeding time and another device was used.Patient consequence was not reported.
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Manufacturer Narrative
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(b)(4).Date sent: 1/4/2021.D4: batch # u9380c.H6: component code: others (g07) the analysis results found that the mcm20 device was returned with no apparent damage and with a clip in the jaws.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 thirteen conforming clips.The event described could not be confirmed as the device performed without any difficulties noted.Although there is no direct evidence of use error, the instructions for use do contain the following: "caution: once the clip completely surrounds the vessel or tubular structure to be ligated and prior to starting the firing stroke, eliminate downward pressure so the structure to be ligated and the device jaws are pressure neutral to each other.This helps prevent the shifting of the clip position within the clip track and/or dislodgement." 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.Additional complaint information monitoring for potential safety signals will be 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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