|
Model Number 174233 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 03/26/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the plastic cable sheath had shearing damage and was bent.A functional evaluation found that jaw rotation worked without difficulty.Release lever and jaw toggle functioned properly.Ratchet button functioned properly.Jaw articulated, opened and closed without difficulty.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur where an excessive force or leverage is applied to the device while retracting the clevis assembly and the clevis boot is subsequently damaged.This subsequent damage may result in improper retraction and deployment of the jaws during articulation and may cause shearing of the plastic cable sheath.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, prior to use on a laparoscopic procedure, when the surgeon was checking extension, rotation and articulation of the device before patient entering the operating room, when it was extended it appeared to shear opaque plastic on the shaft of the instrument.The new instrument was used to complete the case.There was no patient involvement.
|
|
Search Alerts/Recalls
|
|
|