Model Number 000451 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the user recently had issues where the end was breaking off from the bulb where the rubber tubing was attached.This tubing was normally pulled off and their own silicone tubing was attached and olympus adaptor, as the surgeons found that the tubing supplied was too flimsy.They had been doing that for years without a problem; however, recently the entire end was breaking off in their hands, leaving the product useless.The reported issue seemed to be related to only one lot number which was removed.There was approximately 4 to 5 discarded before it was realized that this was an issue.There have been no other incidents with the other lot numbers.
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Event Description
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It was reported that the user recently had issues where the end was breaking off from the bulb where the rubber tubing was attached.This tubing was normally pulled off and their own silicone tubing was attached and olympus adaptor, as the surgeons found that the tubing supplied was too flimsy.They had been doing that for years without a problem; however, recently the entire end was breaking off in their hands, leaving the product useless.The reported issue seemed to be related to only one lot number which was removed.There was approximately 4 to 5 discarded before it was realized that this was an issue.There have been no other incidents with the other lot numbers.
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Manufacturer Narrative
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The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.".
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Search Alerts/Recalls
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