Catalog Number 0220180518 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was a conversion to open procedure.
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Manufacturer Narrative
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Alleged failure: unable to see laparoscopically with 2 of the 5 and have one to send back.Salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be the light source console the u-kit was connected to had a broken laser diode.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufactured date is unknown.
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Event Description
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It was reported that there was a conversion to open procedure.
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Search Alerts/Recalls
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