Catalog Number 0250080361 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that the forceps did not work which resulted in the procedure converting to open surgery.
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Manufacturer Narrative
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Alleged failure: during surgery process, bipolar forceps can¿t power and can¿t made blood coagulation.So, this issue happened lead to the surgery options was changed from minimally invasive surgery to open operation.The procedure finished by used a new replacement.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as it was unable to be confirmed.However, there is physical damage sustained to the unit which could have occurred as a result of excessive force or mishandling.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The device manufacture date is not known.
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Event Description
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It was reported that the forceps did not work which resulted in the procedure converting to open surgery.
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Search Alerts/Recalls
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