Catalog Number C2600 |
Device Problem
Output Problem (3005)
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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 3 of 3 reports linked to mfg report numbers 3006697299-2023-00089 and 3006697299-2023-00090: a facility reported that during use of the cusa excel handpiece (unknown catalog#), the cusaexcel9 console emitted a "cooling alarm." additional information was received as follows: when was the issue discovered (before, during, after surgery)? answer : during ¿ was the patient already under anesthesia? answer : yes ¿ was the patient injured? if yes, please describe injury and treatment.Answer : no ¿ did the event lead to increase surgery time? if yes, for how long? answer : maybe 30 minutes, they had to change the handpiece two times.The third and last handpiece gave no problems.¿ how did the medical staff finish the procedure (using replacement unit¿)? answer: see above answer.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: d1, d4, d9, g3, g6, h2, h3, h10.Additional information received; therefore, catalog# and brand name have been updated.
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Manufacturer Narrative
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The cusa excel 23khz straight handpiece (c2600) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Failure analysis - evaluation was unable to conclusively verify customer information as valid.No fault was found, and the device passed all cosmetic and functional testing and meets specification.No issue was determined.However, annual preventive maintenance was performed, and the housing and o-rings were replaced.A full function test including calibration and safety test according to the manufacturer's specifications was performed.Root cause - the complaint was not confirmed, as the device met specifications.Possible root causes of the reported issue are: cooling water reservoir not properly seated.A pinch or kink in the handpiece.Handpiece cable not properly connected to console no further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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Search Alerts/Recalls
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