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

Model Number	DMR ATA 2.4
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The incident occurred during a therapist training session in france, specifically during the patient session (final session of the training program).At the time of the event, the trainee operator did not follow established training instructions and safety procedures for securing the exoskeleton to the overhead safety rail.Specifically, the operator attached the device to the rail using a thin metal cable intended solely to prevent the swivel retaining screws from loosening, rather than using the designated swivel hook, which is the correct and load-bearing attachment point.A temporary imbalance was noted during the session, without indication of device malfunction.The event occurred in a context of inadequate adherence to established operating procedures and reduced operator vigilance during device setup and use.As the metal cable is not designed to support the weight of the device, it failed under load, resulting in a lateral fall of the exoskeleton.No injuries were reported (no bruising, fractures, or other harm).The patient was reassessed several days later, and the absence of injury was confirmed.While the outcome was benign, the incident had the potential to result in serious injury.Human factors / abnormal use conditions: the incident occurred in a context of operator non-compliance with training instructions and reduced situational awareness during device setup.The operator misidentified the correct attachment point despite prior training and clear instructions provided in both the user manual and the training program.The metal cable used is visibly thinner and mechanically unsuitable as a load-bearing connection.However, it currently lacks explicit design cues (e.G., color coding, labeling, or a physical deterrent) to prevent it from being mistakenly used as the primary attachment point, which may increase the likelihood of misuse under conditions of inattention or deviation from standard operating procedures.Although the safety system as described in detail in the user manual, is safe when used as intended, and safety procedures are thoroughly addressed during training particularly regarding correct attachment points, this event highlights opportunities to further improve usability and error-proofing to mitigate the risk of improper use, especially in situations where established procedures are not strictly followed.

• Brand Name: ATALANTE X
• Common Device Name: POWERED LOWER LIMB EXOSKELETON
• Manufacturer (Section D): WANDERCRAFT SAS; 88 rue rivoli; paris, 75004 ; FR 75004
• Manufacturer (Section G): WANDERCRAFT SAS; 88 rue rivoli; paris, 75004 ; FR 75004
• Manufacturer Contact: maria ida iacono ; 88 rue rivoli; paris, 75004 ; FR 75004
• MDR Report Key: 23851368
• Report Number: 3015000676-2025-00002
• Device Sequence Number: 9361639
• Product Code: PHL
• UDI-Device Identifier: 3665965000075
• UDI-Public: (01)3665965000075(11)250708
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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
• Device Model Number: DMR ATA 2.4
• Device Lot Number: 07/082030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 74 KG