Model Number IMH-20 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned for evaluation.Estimation inspected the device and determined that a software update was required.No physical damage was noted.The instruction manual states ¿before using this instrument, be sure to inspect and set it up as described in this chapter.Also inspect the ancillary equipment to be used in combination with this instrument as described in the instruction manuals for the equipment.If any irregularity is observed with this instrument, do not use it and take remedial actions as described in chapter 8, ¿troubleshooting¿.If this cannot restore the normal operation, contact olympus.Using this instrument while an irregularity is observed does not only result in malfunction but may also cause an electric shock, injury and/or fire.¿.
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Event Description
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The service center was informed that during a laparoscopic procedure, the image management hub would periodically shut off during recording.The pictures were not recorded and the doctor lost all of the images.There was no damage or abnormalities noted upon inspection.There were no error messages received.The intended procedure was completed.There was no patient injury reported.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information received.Please see the updates in sections: g4, g7, h2 and h10.Additional evaluation findings show the imh-20 tested and passed all functional tests.The service personnel was unable to duplicate the reported complaint.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2 and h10.Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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