Our rep is reporting to us that during an arthroscopic shoulder repair, a portion of the distal tip, or, some foreign matter from a vapr cool pulse electrode broke or came off of the device into the patient's joint space.
The fragment was easily retrieved and the procedure was concluded successfully without further issue or harm to the patient.
The complaint device was received and evaluated visually: both with the naked eye and under power.
Noted: the shaft only was received; it has been purposefully cut away from its handle, which precludes conducting any physical testing.
The complaint narrative states that something at the distal end of the device broke away into the body, however, we cannot discern any damage (outside of the facility's intentional severance) to the device.
The sample was thoroughly examined by several individuals, and they could not see any damage or anomalies to any part of the sample.
The architecture and configuration are totally intact and without any anomaly.
We do not know what the users experience was, but it was not with this device.
The complaint is not confirmed, the device is without fault.
No further action is warranted.