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Model Number 7211004 |
Device Problems
Infusion or Flow Problem (2964); Noise, Audible (3273)
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Patient Problem
Inflammation (1932)
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Event Date 01/11/2022 |
Event Type
Injury
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Event Description
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It was reported that, during a shoulder arthroscopy, when the 'dyonics 25 inflow tube' was plugged-in into the pump, it made a noise, the pump was not priming correctly and caused inflammation in the patient's joint at the beginning of the case, but it was quickly fixed.The procedure was completed without delay using a smith and nephew backup device.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during a shoulder arthroscopy, when the 'dyonics 25 inflow tube' was plugged-in into the pump, it made a noise, the pump was not priming correctly and caused inflammation in the patient's joint at the beginning of the case, but it was quickly fixed.The procedure was completed without delay using a smith and nephew backup device.No further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).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.A review of device records showed 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 was 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.Smith and nephew has not received the device/relevant clinical information to perform a thorough medical investigation nor to determine a definitive root cause of the reported event.Based on the information provided, the issue was quickly fixed, and the procedure was completed without a delay using a s&n back-up.Since no other complications were reported, no further clinical/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.Correction in h6 (health effect - impact code).
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Search Alerts/Recalls
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