Catalog Number ER320 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/20/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: please clarify the clip formation as you described it as "screw/crooked".Did the device fire scissored clips? did the device fire malformed clips? did the device fire the clips sideways? did clips fall off of the tissue? the device fired scissored clips.
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Event Description
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It was reported that during a laparoscopic cholecystectomy procedure, when using the device, unfortunately the clips were screw/ crooked.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.
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Manufacturer Narrative
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(b)(4).Batch # m9121r.The er320 device was returned for analysis and upon inspection the jaws were found to be in a yielded condition.In an attempt to replicate the reported incident the device was functionally evaluated.Upon firing of the device, the remaining clips were ejected due to the condition of the jaws; no scissored clips were formed during the analysis.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.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.The batch record was reviewed and no anomalies were noted during the manufacturing process.
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Search Alerts/Recalls
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