Catalog Number ER320 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the clip not close? or, did the jaws of the device not close to form the clip?.
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Event Description
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It was reported that during a laparoscopic cholecystectomy, when firing the device, the clip was loading but would not close.A repeat device was opened to replace.
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Manufacturer Narrative
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(b)(4).Date sent: 06/21/2018.Mdr decision: not reportable additional information was requested and the following was obtained: did the clip not close? or did the jaws of the device not close to form the clip? the jaws of the device would not close to form the clip.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.
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Manufacturer Narrative
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(b)(4).Batch #: r9258v.Device analysis: the er320 device was returned for analysis and upon inspection the jaws were found to be in a yielded condition.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident the device was functionally evaluated.Upon firing of the device, the remaining 8 clips were ejected due to the condition of the jaws; finally the instrument locked out as intended.Possible causes for the found condition of the yielded jaws may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.The reported complaint was confirmed.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.It is known from the history of the device that the condition of the jaws may lead dropping/ejected clips.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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Search Alerts/Recalls
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