Model Number BB515 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported to aesculap ag that a carbon steel scalpel blades #15 (part # bb515) was used during a procedure performed on (b)(6) 2021.According to the complainant, it was reported that the blade was losing the cutting wire very fast and more exchanges were required during the procedure.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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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: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.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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