Model Number 3910-900-091 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/16/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
A statement in additional information received through e-mail states, "he actually stayed with me after the surgery and we tried to pass a piece of cloth, it passed it ok till we bend it a few times to make it "thicker" and the same problem occurred (the needle didn't go through the hole as it should, it passed outside of it without the suture." this indicates enough tissue was grasped that the upper jaw was open to the point where it would not align with the designed path of the needle.The needle has to pass through the upper jaw in order to catch the suture.Where the upper jaw was open too wide from grasping additional tissue the suture was not captured.The suture passer is not designed to grasp this much tissue and the information received indicates the suture passer was being used in a manner other than the way it was designed to be used.This is a known failure mode addressed in the risk management file for this product and does not exceed the occurrence rates.Occurrence rates are monitored for trends.
|
|
Event Description
|
The needled could not go through the rotator's cuff muscle in 9 of 10 times it was used, the one that did pass through the muscle did not bring the suture with it.When they tried the champion suture passer outside the patient, it worked, but in the patient it did not.We changed the needle and the second one worked just fine.No harm was made to the patient, the surgery took 40 minutes longer.Country of event: (b)(6).
|
|
Manufacturer Narrative
|
Update: the needle was returned to coorstek on 8-21-2018.Review of the needle shows a normal bend which indicates it passed through the suture passer with no issues.The needle was loaded into a suture passer and then cycled.The needle cycled through the suture passer and passed through the upper jaw with no issues.The suture passer was then cycled through a simulated tissue sample of normal thickness and passed through the upper jaw with no issues.If excess tissue is grasped it can open the upper jaw to a point where the needle will not pass through the upper jaw.There were no issues found with the returned product.
|
|
Search Alerts/Recalls
|