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Catalog Number 05.001.201 |
Device Problems
Circuit Failure (1089); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: concomitant med products and therapy dates: lid device x 2 (motor cover) and power module device x 3, unknown event date.The initial reporter's phone number was not available.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: serial number unknown; (b)(4).
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the battery handpiece device worked intermittently.According to the reporter, the device would work sometimes and other times it would not work when the trigger was pressed.It was reported that multiple combinations using power module devices and lid devices were tried, however it was unclear which combination of parts caused the device to work intermittently.It was noted that the surgeon suspected that the failure was caused by poor contact.It was also noted that the sales representative checked the device, where it worked when the trigger was pressed and then did not work again until the trigger was pressed multiple times.It was not reported if there were any delays to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the 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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Search Alerts/Recalls
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