Model Number BC283R |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with a tc lexer scissors.According to the complaint description the carbide insert of the scissors broke.The facial layer was split using lexer scissors after a few subsequent cuts were made using lexer scissors, the instrumentation nurse determined that a part of the scissors had broken off.The surgery was stopped immediately.They x-rayed and scanned the surgical field with a metal detector and searched the floor with strong magnets.Unfortunately without success.The broken piece remained undetectable until the end of the surgery.Postoperatively, another x-ray control was performed, where it was also possible to make sure that no foreign material remained in the patient.Type of surgery: laparoscopic appendectomy.An additional medical intervention (additional x-ray) was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
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Manufacturer Narrative
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Investigation results: visual investigation: the analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Multiple damages can be found at the remaining blade.A maintenance has been carried out at ats in 2018.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures: there is no indication for a material defect or manufacturing failure on the basis of the device history records.Based on the investigations and results of the 8d report no capa is necessary.
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Manufacturer Narrative
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Customer changed.
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Search Alerts/Recalls
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