|
Model Number CP-424 |
Device Problems
Break (1069); Loose or Intermittent Connection (1371); Material Too Soft/Flexible (4007)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, intraoperatively, the needle broke and the suture was loose when tying.They opened a new one to complete the case.The patient injury was asked but it was unknown.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Visual inspection of the sample noted two needles with partial sutures attached to them.One of them had a knot.The needle was intact with only instrument marks.Unfortunately, as no sealed samples were returned, a bend moment test could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|