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 07/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (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 pivot pin got detached during a surgery.Therefore, the applier was replaced with a new one.Nothing fell/remained in the patient.The applier was purchased by the hospital in (b)(6) 2021.
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Event Description
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It was reported that the pivot pin got detached during a surgery.Therefore, the applier was replaced with a new one.Nothing fell/r emained in the patient.The applier was purchased by the hospital in (b)(6) 2021.
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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 (b)(6) pc.Lot in may of 2020.Evaluation of the returned instrument shows that the tips are loose and misaligned , and the jaw pivot pin is pulled thru one side of the damaged/bent outer tube assembly.We are able to validate this complaint.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod (n00185) is bent /damaged.We are unable to determine what caused the drive rod to become damaged and for the jaws to become loose and misaligned 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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Search Alerts/Recalls
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