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Model Number 71430416 |
Device Problems
Crack (1135); Naturally Worn (2988); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during sterilization procedures, the following items were noticed to be worn and have cracks scratches and gouges: gii ps hi flex isrt tr s3-4 9 ((b)(4)), gii ps hi flex isrt tr s5-6 9 ((b)(4)) and gii ps hi flex isrt tr s5-6 11 ((b)(4)).No case involved; therefore, no patient was involved.
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Manufacturer Narrative
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H6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The surface of the returned device has various gouges and missing material rendering the device inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
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Search Alerts/Recalls
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