DEPUY SYNTHES PRODUCTS LLC BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.710 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Injury (2348); Foreign Body In Patient (2687)
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Event Date 03/05/2020 |
Event Type
Injury
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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.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: (b)(4).
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Event Description
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It was reported that during an unspecified surgical procedure, it was discovered that the battery oscillator device leaked fluid in the patient.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.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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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device.During evaluation, it was determined that the device passed all pre-repair diagnostic assessment specifications and no failure was identified.Therefore, the reported condition was not confirmed, and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H6: service history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a service history review was performed which indicated that the device was serviced within the last year for a service condition that is not relevant to the current reported condition.Manufacturing record evaluation (mre) review: a manufacturing record evaluation (mre) was performed and identified that servicing was completed within one year.Therefore, any potential relationship to the reported condition could not be determined.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.
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Search Alerts/Recalls
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