Model Number IPN915189 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2021 |
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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The pivot pin was found loose during a pretest before use.Therefore, a new unit was used instead.The applier was purchased by the hospital within 1 year.
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Event Description
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The pivot pin was found loose during a pretest before use.Therefore, a new unit was used instead.The applier was purchased by the hospital within 1 year.
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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)(4) pc.Lot in may of 2020.Evaluation of the returned instrument shows that the tips are slightly loose and misaligned in the closed position, but the jaw pivot pin is not loose as stated in the complaint.This instrument was received with all of its components intact.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) bosses are both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused the drive rod bosses to become damaged but mishandling of this device at the end user's facility is suspected.All (b)(4) 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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