ARTHROCARE CORP. SUPER TURBOVAC 90 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number ASC4250-01 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2020 |
Event Type
Injury
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Event Description
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It was reported that, during an arthroscopy, the super turbovac could not be activated as intended, the power was weak to ablate tissue.The procedure was completed with a shaver system.No delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Internal complaint reference (b)(4).H10 h3, h6: the device, used in treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated issue.A review of the instructions for use found statements related to output settings.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the device showed minimal erosion of the screen/electrodes and some discoloration of the spacer.The device was connected to a known good controller and the wand was tested at default and maximum settings, which revealed that the device performed as intended.The suction line performed as intended.The complaint was not verified and a root cause could not be determined as the device performed as intended.Factors, which may have contributed to the reported complaint include: 1) the device may have been used below default settings.2) there may have been an issue with one of the concomitant devices in use at the time of this complaint event.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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