ARTHROCARE CORP. UNKN ENT REFLEX ULTRA PLASMA WAND AND TURBINATOR WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number UNKN04300101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Abscess (1690)
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Event Date 01/06/2009 |
Event Type
Injury
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Event Description
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It was reported that on literature review "the treatment effect for obstructive sleep apnea-hypopnea syndrome with radio frequency ablation surgery", one patients had a abscess formation at the lingual root after a radiofrequency ablation procedure using a reflex 45, reflex 55 wand and a coblator ii surgery system.The event was resolved with antibiotics and also by making another incision for drainage.Patient outcome is unknown.No further information is available.
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Manufacturer Narrative
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Internal complaint reference (b)(4).Article cite: mu s, sun c, song j, liu l, qu y, liu l, cui l, zhao l, yin w, wang l.[effect and indications of radiofrequency ablation for the treatment of obstructive sleep apnea-hypopnea syndrome].Lin chung er bi yan hou tou jing wai ke za zhi.2007 nov;21(21):981-4.Chinese.Pmid: 18309654.
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Manufacturer Narrative
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H10: h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record, complaint history, device labeling/ifu, risk management and capa, nc, pra/hhe review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The article provided was not presented in a readable format.Per case details no further information is available, and no sample will be returned.Without supporting clinical/medical documents, a thorough investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional clinical information be provided this complaint will be re-evaluated.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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