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Model Number MIC1332 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not yet been returned to the manufacturer at the time of this report.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 the device was tested by opening and closing prior to placing it in the scope.Upon opening while in the patient to retrieve a biopsy, the forceps broke.Fragments or pieces were not left in the patient.No harm was detected to patient.Additional information was requested, but additional information is not available.
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Manufacturer Narrative
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The device was returned to the manufacturer with clearly damaged jaws including a compromised mechanism for opening and closing the jaws.While the jaws of the device were able to open and close, the alignment was off as well as clear and present damage.Due to the presence of contaminants as well as the statement of use following function testing in the field, the root cause was likely misuse or mishandling in the field.
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Search Alerts/Recalls
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