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Catalog Number EMAX2PLUS |
Device Problems
Break (1069); Moisture Damage (1405); Defective Device (2588); Naturally Worn (2988)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that gears on the motor device were damaged.It was further noted that the device had liquid damage, the motor and control were defective, and the hose was worn.It was noted in the service order that the device had a torn hose and did not work at all.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition of the device not working was not confirmed.Therefore, an assignable root cause was not determined.However, it was determined that there was tear in the hose (cord) due to mishandling of the device by allowing the cord to come in contact with a sharp object which punctured the cord or exerting extreme force on the cord during cleaning or use.The assignable root cause was determined to be due to cleaning, sterilization and/or maintenance procedures not followed per directions for use.This was further defined as user error / abuse and possibly misuse.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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