Catalog Number 443A1000 |
Device Problem
Device Reprocessing Problem (1091)
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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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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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This is 1 of 3 reports for part #443a1000, linked to mfg report numbers: 3004608878-2022-00159; 3004608878-2022-00160.A facility reported that the 3 parts of the radiolucent halo ring assembly shrunk in the first sterilization cycle which made it impossible to use because they were not getting connected to each other.The incident occurred during the first surgery itself as the whole system had never been used.The medical staff had to change the entire radiolucent mayfield system to standard mayfield system and use the standard budde halo for the surgery.There was no patient injury since it was not used on the patient; however, this led to increased surgery time of 90 minutes.
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Manufacturer Narrative
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The radiolucent budde halo retractor system (a1096) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - inspection of the returned budde halo system confirms the reported complaint.The two halves of the halo ring were not able to be connected completely at the starburst teeth.The frame of the budde halo can become altered and subsequently not fit correctly following routine use and sterilization cycles.Root cause - this device is subject to wear from routine use and as a result requires routine service and preventive maintenance.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Search Alerts/Recalls
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