MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for EKSO EKSO GT NA manufactured by Ekso Bionics, Inc..
[24151920]
This device was returned to mfr for eval was retained. Mfr determined that component formed a crack ((b)(4)) under bending stresses greater than the design load of the component, and subsequently fractured ((b)(4)) due to fatigue causing the leg structure to separate from the device ((b)(4)). Preliminary investigation shows that this malfunction was likely due to a simultaneous combination of events. Evidence exists of device mishandling ((b)(4)); evidence exists of damage in shipping; evidence exists of damage from previous rework. Results pending completion of eval and root cause is still under investigation. Additional info follow-up will be submitted when the following info becomes available: (d2b) this device is currently registered under procode bxb as indicated in (d2b). This device is currently pending 510 (k) approval under procode phl. Eval results and conclusion - as root cause is still under investigation. Remedial action - root cause is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[24151921]
Upper left leg structure became separated from the device during the physical therapist session. The device went into a safe mode status as designed. The pt was lowered into a chari and was safely removed from the device by the physical therapist who was walking with the pt as per training protocol. The pt sustained no injuries and no medical follow-up or intervention was needed. No physical therapists, therapists, or third persons have been affected or injured.
Patient Sequence No: 1, Text Type: D, B5
[40345709]
Root cause was the abduction and adduction forces experienced by the leg assembly produced stresses higher than the design stress of the uddl. Low risk failure due to safeguards in place eliminating any realistic possibility of patient harm. Design improvements were identified, which further increase the durability of the device. 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
[40345710]
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 | 3009495988-2015-00002 |
| MDR Report Key | 5021118 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-12 |
| Date of Event | 2015-07-14 |
| Date Mfgr Received | 2015-07-10 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2015-08-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 S STE 1201 |
| Manufacturer City | RICHMOND CA 94804 |
| Manufacturer Country | US |
| Manufacturer Postal | 94804 |
| Manufacturer Phone | 5109841761 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EKSO |
| Generic Name | EKSO GT |
| Product Code | PHL |
| Date Received | 2015-08-12 |
| Returned To Mfg | 2015-07-17 |
| Model Number | EKSO GT |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | EKSO BIONICS, INC. |
| Manufacturer Address | RICHMOND CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |