Ekso Bionics EksoNR: knee swelling and a left motor overheating during sit-to-stand (FDA MAUDE)
[INJURY]Apr 14, 2023 · Ekso Bionics · EksoNR · United States
Failure Mode
INJURY
Event Date
Apr 14, 2023
Primary Entity
Ekso Bionics
Robotic Platform
EksoNR
Jurisdiction / Location
United States
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
An FDA MAUDE injury report describes an Ekso Bionics EksoNR exoskeleton overheating its left motor with associated knee swelling during a sit-to-stand transition. Ekso has no FDA device recalls on record; its FDA safety signal is in MAUDE. Source: FDA MAUDE MDR key 16906337, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
System & Fleet Architecture
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- Inspect Filing
https://eksobionics.com/
https://eksobionics.com/
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6740206&pc=PHL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6740206&pc=PHL
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Details
Incident Context & FAQ
What happened in Ekso Bionics EksoNR: knee swelling and a left motor overheating during sit-to-stand (FDA MAUDE)?
An FDA MAUDE injury report describes an Ekso Bionics EksoNR exoskeleton overheating its left motor with associated knee swelling during a sit-to-stand transition. Ekso has no FDA device recalls on record; its FDA safety signal is in MAUDE. Source: FDA MAUDE MDR key 16906337, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on April 14, 2023 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Ekso Bionics EksoNR: knee swelling and a left motor overheating during sit-to-stand (FDA MAUDE)?
EksoNR by Ekso Bionics is the recorded robot involved in this incident at United States.
Has anyone responded to Ekso Bionics EksoNR: knee swelling and a left motor overheating during sit-to-stand (FDA MAUDE)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Ekso Bionics EksoNR: knee swelling and a left motor overheating during sit-to-stand (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.