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Catalog Number 72202589 |
Device Problems
Break (1069); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference (b)(4).
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Event Description
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It was reported that during set up, the suture cutter was found to be locked.It is unknown if there was a back-up device available or if there was a delay.There was no patient involvement.Per the preliminary results of the investigation, the visual inspection showed the distal end of the cutting shaft is fractured away from the proximal end that is attached to the handpiece.
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Manufacturer Narrative
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H10 h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device shows definite wear from use, the laser etchings are legible.The distal end of the cutting shaft is fractured away from the proximal end that is attached to the handpiece.A functional assessment of the device found it cannot function as designed due to the fractured cutting shaft.These failures have been determined to be related to the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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.The root cause was associated with an unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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Manufacturer Narrative
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H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device shows definite wear from use, the laser etchings are legible.The distal end of the cutting shaft is fractured away from the proximal end that is attached to the handpiece.A functional assessment of the device found it cannot function as designed due to the fractured cutting shaft.These failures have been determined to be related to the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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.The root cause was associated with an unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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