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Model Number IPN915189 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2022 |
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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It was reported that the user was unable to load a clip to the applier during use.Therefore, another applier was used to complete the procedure.On checking, the jaws were found misaligned.No clips fell/remained in the patient's body.
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Manufacturer Narrative
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(b)(4).The device history review for the returned device was reviewed and found complete without any irregularities.This device was produced at the tecomet, inc, kenosha wi facility as part of a 56-piece lot in march of 2022.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned device as received shows that the tips are slightly loose and misaligned to each other in the closed position.We are able to validate this complaint.Functional evaluation of the returned instrument shows that it is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing.We are unable to determine what caused the jaws to be slightly loose and misaligned in the closed position but mishandling of this device at the end user's facility is suspected.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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It was reported that the user was unable to load a clip to the applier during use.Therefore, another applier was used to complete the procedure.On checking, the jaws were found misaligned.No clips fell/remained in the patient's body.
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Search Alerts/Recalls
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