Model Number 121186 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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It was reported that during a heart operation, the surgeon noticed that a piece of the debakey carb-bite needle holder (121186) was missing.Before the end of the operation, an x-ray test was done.The missing piece was not found in the patient¿s body.Medical staff did not know at which stage the device broke, but suspected it was at the beginning of the operation.The event did not lead to patient injury; however, a two-hour increase in surgery time was reported.
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Manufacturer Narrative
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The suspected carb-bite debakey needle holder (121186) was returned for evaluation: the needle holder was received in used condition with part of the tip's carbide grip broken off.Per the customer, this product had been purchased in 2011.The issue of grip breaking off may be the result of wear or environmental damage.The reported complaint was confirmed.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Manufacturer Narrative
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The suspected carb-bite debakey needle holder (121186) was returned for evaluation: the needle holder was received in used condition with part of the tip's carbide grip broken off.Per the customer, this product had been purchased in 2011.Inspection by the current supplier for this product identified that it was manufactured by a previous supplier in 2010.The issue of grip breaking off may be the result of wear or environmental damage.The reported complaint was confirmed.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Event Description
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N/a.
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Search Alerts/Recalls
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