Model Number 012001 |
Device Problem
Failure to Cut (2587)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/13/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during laparoscopic living donor nephrectomy, the device could not cut even it was activated.They used another device to continue.There was no patient injury.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during laparoscopic living donor nephrectomy, in the middle of use, the device could not cut at all even it was activated.They used another device to continue.There was no patient injury.
|
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a surgical procedure.The instrument registered a mechanical fault.The instrument was disassembled; a crack was noticed in the proximal portion of the probe shaft.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 cracked probe shaft may occur when the probe shaft makes contact with the outer tube while the system was energized.The information for use for this product states, avoid using the device as a lever, either while dissecting or while activating the instrument.Added stress to the tip may cause the probe to touch in the inner tube portion of the instrument, resulting in mechanical failure and/or rendering the instrument inoperable.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.No relationship between the device and the reported incident was confirmed.No enhancements or improvements were generated for the reported condition.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|