DEPUY SYNTHES PRODUCTS LLC KINCISE¿ RECHARGEABLE LI-ION BATTERY; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1002-00-102 |
Device Problems
Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2024 |
Event Type
malfunction
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Event Description
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It was reported that during sterile processing, it was observed that the battery device was leaking.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: udi : (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: idevice history review review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.
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Search Alerts/Recalls
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