Model Number 72200873 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that during a shoulder arthroscopic surgery, the power handle cable of the dll controller was heated and sometimes did not work.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.
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Manufacturer Narrative
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Corrected data: description of the event.
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Event Description
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It was reported that during a shoulder arthroscopic surgery, the dll controller power cable was heated and sometimes did not work.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H2: additional information: d1, d2 and d4: catalog number and udi number.
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Manufacturer Narrative
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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.There was no relationship found between the device and the reported event.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 similar reported events a risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.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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Search Alerts/Recalls
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