Catalog Number 8065752415 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/06/2023 |
Event Type
malfunction
|
Event Description
|
A nurse reported that the probe was able to cut but unable to suck and suction tubing detached during vitrectomy surgery.The surgery was completed after replacing the product with another one.There was no patient harm.
|
|
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).
|
|
Manufacturer Narrative
|
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The returned sample was visually inspected and confirmed the clear line on the probe was detached due to lack of solvent.The root cause of the customer's complaint is to the assembly process of the probe manifold.The clear line detached from the probe engine due to lack of solvent.Action will not be taken for this occurrence.Per our most recent trending, no associated trend alert(s) were observed.All complaints are reviewed on a monthly basis, and corrective actions will be defined if required.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|