RegistryTMR-0101
Asensus Surgical issued a customer alert on September 15, 2023, warning that the Senhance surgical robot's laparoscope instrument actuator could rotate continuously after disconnection from its remote control, posing a risk of tissue trauma, though no patient harm occurred, and the FDA classified it as a Class I recall.
- Date of incident
- 2023-09-15
- Location
- not established
- Model
- Senhance
- Sources
- 1
EscalationReport
How the event developed
- 2023-11-17Report
Asensus Surgical issued a customer alert on September 15, 2023, warning that the Senhance surgical robot's laparoscope instrument actuator could rotate continuously after disconnection from its remote control, posing a risk of tissue trauma, though no patient harm occurred, and the FDA classified it as a Class I recall.
fiercebiotech.com
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