SYNTHES GMBH BATTERY RECIPROCATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.715 |
Device Problems
Device Reprocessing Problem (1091); Leak/Splash (1354); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2022 |
Event Type
malfunction
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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.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.The reporter¿s name, complete address and phone number were not provided.Device evaluation: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
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Event Description
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It was reported from japan that during an unspecified surgical procedure, it was discovered that water was leaking out of the battery reciprocator device when the nurse touched the black part with white arrow to change orientation of the reciprocating blade.The sterilization was attempted again but the device repeated.There were no 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.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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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.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.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the trigger of the device did not run smoothly and traces of liquid was found on multiple parts.It was further determined that the device failed pretest for checking for sticky trigger.It was further reported that the device had foreign substance/debris/cleaning/sterilization.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure from normal wear.
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Search Alerts/Recalls
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