Model Number VNL8-J10 |
Device Problems
Inaccurate Synchronization (1609); Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2021 |
Event Type
malfunction
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Event Description
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There is a large amount of angle play and there are areas that do not follow.There is no trauma or leak, and the symptoms have occurred about one year after purchase, so the facility is not convinced.Since it occurred before use, there is no health hazard to patients and medical staff.
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Manufacturer Narrative
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If additional information becomes available, a supplemental report will be filed with the new information.
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Manufacturer Narrative
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Evaluation summary: we checked the returned unit and confirmed that the distal body worn out.Based on the result, we concluded that it was caused due to the physical damage applied on the body.In addition, we confirmed that the bending rubber worn out; however, it is not the main cause, and/or irrelevant to the alleged complaint.
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Search Alerts/Recalls
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