Model Number BM067R |
Device Problem
Material Fragmentation (1261)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2021 |
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.Incident reported under (b)(4).
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Event Description
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It was reported that there was an issue with bm067r - tc mayo-hegar ndl holderhvyserr205mm.According to the complaint description, during cesarean section procedure part of a needle driver insert fell into a patient.An additional medical intervention was necessary.Additional information was not provided nor available.The malfunction is filed under (b)(4).
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Event Description
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Clarification was received: there was no delay caused by the breakage in the original surgery.However, postoperatively, the patient underwent another procedure (no specified), as well as attending multiple physician appointments, and required the performance of additional x-rays.
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Manufacturer Narrative
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B5 - description updated.E1 - reporter updated.H6 - codes updated.
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Manufacturer Narrative
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Incident reported under (b)(4).Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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 / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
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Search Alerts/Recalls
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