Model Number TABLETOP-JAPAN |
Device Problems
Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that system turned off, laser probe struck in the connector part of the system and the laser went to standby mode during surgery.There was no impact noted on surgery.There was no report of any patient harm.
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Manufacturer Narrative
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There was no request for service at this time and there was no further information provided from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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