MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2015-11-16 for EKSO manufactured by Ekso Bionics, Inc..
[31277607]
Results pending completion of evaluation and root cause is still under investigation. Additional information follow-up will be submitted when the following information becomes available: this device is currently registered under procode bxb as indicated. This device is currently pending 510(k) approval under procode phl. Relevant tests - as device is pending return to usa headquarters. Method, evaluation results and conclusion - as device is pending return to usa headquarters and root cause is still under investigation. Remedial action - root cause is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[31277610]
During straight walking, the upper left leg structure became separated from the device during the therapist session. The patient was lowered into a chair and was safely removed from the device by the physical therapist who was walking with the patient. The patient sustained no injuries and no medical follow-up or intervention was needed. No therapists or third persons have been affected or injured.
Patient Sequence No: 1, Text Type: D, B5
[40341995]
Root cause was the abduction and adduction forces experienced by the leg assembly produced stresses higher than the design stress of the uddl. The device had over a million steps. Remedial action: redesign uddl to lower the peak stresses without changing overall stiffness to extend durability beyond service life. Since this failure mode represents a low risk of injury the corrective actions will be made at the next routine service period.
Patient Sequence No: 1, Text Type: N, H10
[40341996]
This event did not lead to an injury and there have been no injuries reported since the mdr was filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009495988-2015-00007 |
| MDR Report Key | 5225095 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2015-11-16 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-10-16 |
| Date Mfgr Received | 2015-10-22 |
| Device Manufacturer Date | 2013-01-03 |
| Date Added to Maude | 2015-11-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DOUG HUMPHREY |
| Manufacturer Street | 1414 HARBOUR WAY SOUTH SUITE 1201 |
| Manufacturer City | RICHMOND CA 94804 |
| Manufacturer Country | US |
| Manufacturer Postal | 94804 |
| Manufacturer Phone | 5109841761 |
| Manufacturer G1 | EKSO BIONICS, INC. |
| Manufacturer Street | 1414 HARBOUR WAY SOUTH SUITE 1201 |
| Manufacturer City | RICHMOND CA 94804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94804 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EKSO |
| Generic Name | EKSO |
| Product Code | PHL |
| Date Received | 2015-11-16 |
| Returned To Mfg | 2015-10-22 |
| Model Number | EKSO |
| Operator | PHYSICAL THERAPIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | EKSO BIONICS, INC. |
| Manufacturer Address | 1414 HARBOUR WAY SOUTH SUITE 1201 RICHMOND CA 94804 US 94804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-16 |