|
Model Number HAR36 |
Device Problems
Mechanical Problem (1384); Noise, Audible (3273)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/10/2015 |
Event Type
malfunction
|
Event Description
|
It was reported that a har36 ultrasonic scalpel was making a sizzling noise.There was no medical intervention, surgical delay, or adverse consequences.The procedure was completed successfully.
|
|
Manufacturer Narrative
|
The complaint device was returned to stryker sustainability solutions for evaluation.Inspection of the returned device revealed evidence of clinical use including biological material on the distal tip and an indention in the teflon pad.The shaft rotation and the jaw actuation of the device were found to be acceptable.The device was connected to a generator and failed with two "tighten assembly" errors (after which the assembly was tightened) and a "replace instrument" error.The device was examined further and a build up of tissue/fluid was noticed along the rod which can disrupt harmonic frequency and reduce cutting ability.The rod was inspected for fractures, and none were found.The distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which would allow fluid/tissue to rise up the rod.The cause of tissue/fluid build up is damage to the distal gasket; action is being taken to address this issue.Tissue build up due to distal gasket damage can disrupt harmonic frequency and potentially reduce cutting ability, therefore the reported complaint was confirmed.
|
|
Search Alerts/Recalls
|
|
|