Catalog Number 8065000095 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/16/2021 |
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 physician reported a vitrectomy probe's outer cylinder came off from its root during a cataract-vitrectomy procedure.It was removed from the eye via aspiration.The procedure was completed after replacing the product with another one.There was no patient harm.
|
|
Manufacturer Narrative
|
The returned sample was visually inspected and found to be non-conforming with the needle/stiffener assembly separated from the rest of the probe assembly.The probe sample was disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Inner cutter was observed to be slightly bent.Gouge marks were observed at a couple locations along the inner cutter.The product was processed and released according to the product¿s acceptance criteria.The evaluation confirms the reported issue of outer cylinder of cutter came off.The root cause for the component detachment is the adhesive bond failure which caused the needle assembly to detach from the rest of the probe assembly.An internal investigation was completed and improvements to the adhesive bond have been identified.A photo of the returned sample has been issued within the learning management system for review with the applicable production personnel to raise awareness of this issue.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed for this reported event.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|