Model Number 190075 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Event Description
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During procedure, a physician stopped using the jawz as the jaws couldn't open/close in body.As a result of the returned sample(s) review at gmkk: unable to manipulate the jaws due to the broken handle.Detached core wire from the handle was found.
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Event Description
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During procedure, a physician stopped using the jawz as the jaws couldn't open/close in body as a result of the returned sample(s) review at gmkk: unable to manipulate the jaws due to the broken handle.Detached core wire from the handle was found.
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Manufacturer Narrative
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A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.No sample was returned for evaluation, however images were provided.Upon viewing the images it was found that the actuating wire had come out of the ferrule used to hold it under the grub screw.Thereby confirming the complaint.A scar# scar-00026 has been issued to notify the supplier viant as&o holdings, llc that an investigation is necessary.Per the supplier's investigation, they will take necessary corrective measures.
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Search Alerts/Recalls
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