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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 08/23/2021 |
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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Hemolok endo applier 5mm ml, clips not locking due to non functioning of jaws, jaws dislocated.
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Event Description
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Hemolok endo applier 5mm ml, clips not locking due to non functioning of jaws, jaws dislocated.
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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 irregularities.This instrument was produced at the tecomet , inc.Kenosha wi facility as part of a 50-piece lot in march of 2018.Evaluation of the returned instrument as received shows that the luer flush port cap is missing and the jaws are slightly loose and misaligned in the closed position thus we are able to validate this complaint.Further evaluation shows that the knob rotation and handle to jaw mechanisms are both dry and sluggish feeling suggesting that this instrument is in need of proper lubrication.After the initial evaluation this instrument was disassembled 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.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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