Model Number IPN915189 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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The jaws of the applier did not release clips smoothly while in use.No clips fell/remained in the patient.
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Manufacturer Narrative
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Qn#(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc.Kenosha.Wi facility as part of a 50 pc.Lot in june of 2020.It was also found that this order was made from the correct materials and components and all processes were followed.Review of returned instrument shows that both the handle to jaw and knob rotation mechanisms are dry and sluggish feeling thus we are able to validate this complaint.After the initial review this instrument was properly lubricated using non-silicone water based instrument lube as recommended in ifu l02425 r01 which was supplied with the instrument at time of production and both the handle to jaw and knob rotation mechanism were returned to a normal free feeling state as they were at time of production.It is suspected that this instrument was not properly lubricated prior to sterilization at the end user's facility.All 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings , no further actions will be taken in response to this complaint and this record will be deemed closed.
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Event Description
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The jaws of the applier did not release clips smoothly while in use.No clips fell/remained in the patient.
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Search Alerts/Recalls
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