|
Catalog Number 0115312 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/05/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
As reported, the x-large 3dmax mesh ripped during insertion through a 12 mm laparoscopic port.The subject device was returned for evaluation.Initial evaluation finds multiple visible frays/tearing in the edge seal of the mesh.No manufacturing anomalies were found.Per the instructions for use (ifu), "the size of the extra-large bard 3dmax mesh may inhibit deployment through a trocar.Use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force.If mesh will not easily deploy down the trocar, remove trocar and insert mesh through incision.Reinsert trocar." based on the sample evaluation and investigation performed, the root cause is determined to be user/device interface while deploying the x-large mesh down the 12mm trocar.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june, 2021.
|
|
Event Description
|
As reported, during a laparoscopic left inguinal hernia repair procedure on (b)(6) 2021, a x-large bard/davol 3dmax left mesh was inserted through a 12 mm trocar.Once the mesh was pushed through completely, it was noted that the mesh had torn along the edges.As reported, the mesh was removed from the patient and another x-large 3dmax mesh was used to complete the case.As reported, there was no patient harm or injury.
|
|
Search Alerts/Recalls
|
|
|