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 06/18/2021 |
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 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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Manufacturer Narrative
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(b)(4).The dhr for the returned instrument was reviewed and found completely without any nonconformance's or irregularities.It was also found that this order was made from the correct materials and components.This instrument was produced on shop order 50289610 at the tecomet, inc.Kenosha wi facility as part of a 50-piece lot in march of 2020.Evaluation of the returned instrument shows that the jaws are loose and misaligned , and the jaw pivot pin is pulled thru one side of the bent/damaged outer tube assembly and the drive rod (n00185) is also bent/damaged in the area that it engages the jaws.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) fingers are both damaged where they engage the jaws.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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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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Search Alerts/Recalls
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