MAUDE Adverse Event Report: WANDERCRAFT ATALANTE X; POWERED LOWER LIMB EXOSKELETON

Medical Device Problem Codes	Unstable (1667); Device Tipped Over (2589)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The incident occurred in france at the end of a gait training session using the atalante x exoskeleton with a hemiplegic patient who is 1.90 meters tall (6 feet 3 inches) and weighs 105 kg (231 pounds).The session was supervised by a certified therapist responsible for operating the exoskeleton, and an assistant in charge of the mobile patient lift system to which the exoskeleton was attached.At the conclusion of the session, the exoskeleton automatically returned to the standstill (upright standing) position.The therapist momentarily stepped away to retrieve a bench intended for the exoskeleton to sit on.At the same time, the assistant released the mobile patient lift to engage in conversation with the patient.During this transient loss of direct oversight, the exoskeleton lost lateral balance and pulled the patient lift along with it.The trajectory of the mobile patient lift led it to strike nearby chairs, further compromising its stability.Both the therapist and assistant reacted immediately and were able to catch the exoskeleton and the patient lift before they hit the ground, preventing injury to the patient and to the other persons around.Consequences: · no injury to the patient.· the therapist and the assistant presented with minor injuries, including bruising to the thighs and shins, and mild friction burns from clothing during the intervention.· while no serious outcomes occurred, this situation could have led in more severe injuries.Identified causes: · patient weight exceeded the device's specified limit (105 kg vs.100 kg), which may have compromised stability.· the floor surface was covered with non-slip material, causing excessive friction under the feet of the exoskeleton, potentially preventing a stable return to the standstill position.· lack of simultaneous securing of both the exoskeleton and the mobile patient lift by the clinical staff.· presence of obstacles (chairs) in the fall trajectory, worsening the imbalance.To conclude, no device technical malfunction was identified.The incident appears to have resulted from a combination of human factors and environmental conditions.
Additional Manufacturer Narrative
Wandercraft has initiated a field correction applicable to all atalante x devices when used in combination with mobile patient lifts.This corrective action includes updated intructions for use and enhanced training materials for device operators.

• Brand Name: ATALANTE X
• Common Device Name: POWERED LOWER LIMB EXOSKELETON
• Manufacturer (Section D): WANDERCRAFT; 88 rue de rivoli; paris, ile de france 75004 ; FR 75004
• Manufacturer (Section G): WANDERCRAFT; 88 rue de rivoli; paris, ile de france 75004 ; FR 75004
• Manufacturer Contact: mélanie combes ; 88 rue de rivoli; paris, ile de france 75004 ; FR 75004
• MDR Report Key: 21785658
• Report Number: 3015000676-2025-00001
• Device Sequence Number: 12574930
• Product Code: PHL
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K232077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 04/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3015000676-040325-001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White