Literature case.It was reported that a synovectomy on the left thumb was performed by using a vulcan radio-frequency ablation probe to treat mcpj volar plate instability.The patient had its thumb hyperextensibility resolved; however, it was complicated with infection over the a1 pulley release wound, which required debridement under local anesthetics.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H3,h6: the device, which was used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.A review of the manufacturing records could not be performed because the part number and lot number were not provided.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Factors that are known to contribute to the alleged fault/failure may include a contaminated device.If the product is returned in the future the complaint can be reopened and evaluated.
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