Model Number M00202175926P0 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22f01.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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Event Description
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It was reported to intervascular that while preparing for total arch replacement surgery, discoloration was found as the collagen melted in the product.The operation was completed with another product of the same model stored at the hospital.There was no harm or effect on the patient.Complaint (b)(4).
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Event Description
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Complaint #(b)(4).
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Manufacturer Narrative
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(10/213) the involved device was returned to intervascular for examination.A visual inspection was performed by a quality control (qc) technician and the quality assurance supervisor, they concluded that, at the time of qc the product was in compliance with the specifications.(67) the conducted investigation concludes that the returned product was conform to the specifications.
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Search Alerts/Recalls
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