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Model Number 72202972 |
Device Problems
Material Fragmentation (1261); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).Preliminary results of investigation found that the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident. 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 review of the part drawing found that the drill shaft is straight and in one continuous piece.An analysis of the customer provided image revealed a significant amount of bending and deformation along the drill shaft.A visual inspection of the returned device found that the drill bit is bent and the shaft is fractured in multiple places throughout.The laser etching in the side is worn, and there is debris on the device. the complaint was confirmed. factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.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.
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Event Description
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It was reported that, during set up, the drill flexible endoscpc cann 5mm was damaged.The malfunction was solved with no delays or patient harm using a back up device.Results of investigation have concluded that the shaft of the device is fractured in multiple places throughout which makes it a reportable event.
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Manufacturer Narrative
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H10: h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was an isolated event.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 review of the part drawing found that the drill shaft is straight and in one continuous piece.An analysis of the customer provided image revealed a significant amount of bending and deformation along the drill shaft.A visual inspection of the returned device found that the drill bit is bent and the shaft is fractured in multiple places throughout.The laser etching in the side is worn, and there is debris on the device.The complaint was confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.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.
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Search Alerts/Recalls
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