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Model Number IPN915189 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that the jaws of the applier were found bent before use.Therefore, a new unit was used instead.No patient involvement.
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Manufacturer Narrative
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Qn# (b)(4).The sample was returned and send to the manufacturer (tecomet) for investigation.Tecomet reports: "the dhr for the returned instrument was reviewed and found complete without any irregularities.The instrument was produced at the tecomet, inc kenosha wi facility as part of a 50-pc lot in june of 2022.Evaluation of the returned instrument shows that the tips are loose and misaligned, and the jaw pivot pin is pushed through one side of the damaged/bent outer tube assembly.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 is bent, and its 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.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 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to th e 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 jaws of the applier were found bent before use.Therefore, a new unit was used instead.No patient involvement.
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Search Alerts/Recalls
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