Catalog Number 0504990800 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.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 there was a breach in the sterile barrier.
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Manufacturer Narrative
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The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Through the investigation it was confirmed that rust was not found on the devices inside the sterile packaging, therefore making this event not reportable.Updated rationale from malfunction to no report required.Manufacture date is not known.Alleged failure: the rusty electrodes can be clearly seen before opening the package.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be user dissatisfaction.
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Event Description
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Per investigation results, it is confirmed that rust was not found on the device in the sterile packaging.Therefore making this event not reportable.
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Search Alerts/Recalls
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