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Model Number MIC1332 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to the manufacturer and inspected.The account's reported complaint of black residue on the device has been confirmed however, microvasive biopsy forceps are manufactured with a black ink on its sheath and what the account is referring to as black residue is actually a transfer of the black ink the oem uses during production of the device.There have been no other reported complaints for this issue from other accounts.
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Event Description
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It was reported that following a procedure, during cleaning with tap water and a gauze, black residue was noticed on the device.There has been no patient harm or consequence reported.Follow up has been requested should any further patient information come available.
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Search Alerts/Recalls
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