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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 06/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The account's reported complaint of black residue on the device has been confirmed in previous complaints, 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.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was reviewed and no discrepancies were found.
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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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Manufacturer Narrative
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The device was returned to the manufacturer for evaluation.The wipe down of the device with alcohol reveals that the only portions where there is a black residue where the device has been inked by the manufacturer with black stripes.This is an oem issue, directly related to the manufacture of the device.A complaint query reveals that this is the only account with the black residue complaint.As this is an oem issue, no corrective action has been issued at this time.The black residue has also been confirmed when the same wipe down was performed on an unopened oem product.
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Search Alerts/Recalls
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