Model Number 0747031650 |
Device Problems
Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that debris remained inside the patient.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: noticed ¿fuzzy¿ quality to screen image, not specific to any one case.Then they identified the actual bioburden issue when it was sent out to 3rd-party repair the probable root cause/s could be third party repair and/or improper sterilization methods.
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Event Description
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It was reported that debris remained inside the patient.
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Search Alerts/Recalls
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