Model Number TABLETOP |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431); Failure to Fire (2610)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/19/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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).
|
|
Event Description
|
A healthcare professional reported that an ophthalmic laser did not work and burns.The surgery was completed.The procedure details and patient impact were not reported.Additional information has been requested, but none received to date.
|
|
Manufacturer Narrative
|
The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
The company representative did not confirm nor replicate the reported event.The system was tested and found to meet product specifications.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The system was found to meet specification.Therefore, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|