Model Number 174023 |
Device Problem
Failure to Form Staple (2579)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/19/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during an open procedure, the staples did not folding properly.There was no patient injury.
|
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.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
|