ARTHROCARE CORP. PROCISE XP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number EIC8872-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Post Operative Wound Infection (2446)
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Event Date 01/06/2020 |
Event Type
Injury
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Event Description
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It was reported that on literature review "role of coblation in reducing pain and morbidity of adenoidectomy", 4 patients had one episode and 4 other patients had more than one episode of infections within the first one year after a coblation adenoidectomy procedure using a procise xp or procise max coblation wands.It is unknown how the events were treated.Patients outcome is unknown.No further information is available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Thomas, g., thekkethil, j.S., thomas, s.M., ramesh, s., & vargheses, a.M.(2020).Role of coblation in reducing pain and morbidity of adenoidectomy.International journal of otorhinolaryngology and head and neck surgery, 6(1), 123.Doi: 10.18203/issn.2454-5929.Ijohns20195701.
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Manufacturer Narrative
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Internal complaint reference (b)(4).H10 h3, 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 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.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.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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