MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2015-10-20 for EKSO EKSO GT NA manufactured by Ekso Bionics, Inc..
[28942875]
Affected items were returned to manufacturer for evaluation. Manufacturer determined during preliminary investigation that epoxy bond failure was due to inconsistent epoxy fill as a result of assembly problems causing ankle to internally and externally rotate. Final results are still pending completion of evaluation. Root cause analysis of failure mode is still under investigation and affected items have been retained. This device was repaired and returned to the customer. Additional information follow-up will be submitted when the following info becomes available. A: patient information; customer relations has requested this information from the customer, pending response. : this device is currently registered under procode bxb as indicated in. This device is currently pending 510(k) approval under procode phl. (b)(4) remedial action; root cause analysis is still pending evaluation. Note to fda: submitted via paper since pending esg production account.
Patient Sequence No: 1, Text Type: N, H10
[28942876]
While walking, physical therapist was turning a corner w/the patient and noticed the foot internally rotated. The patient was lowered to a chair and was safely removed from the device. The device was inspected and found that the epoxy bond on the ankle had broken allowing the ankle to rotate. The patient 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
[40348850]
Root cause was handling of the ankle assembly during the manufacturing process before the epoxy adhesive had cured. Remedial action: developed tooling and fixtures to prevent loads from being introduced during epoxy cure time. 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
[40348851]
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 | 3009495988-2015-00006 |
| MDR Report Key | 5168016 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2015-10-20 |
| Date of Report | 2015-10-19 |
| Date of Event | 2015-09-15 |
| Date Mfgr Received | 2015-09-16 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-10-22 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EKSO |
| Product Code | PHL |
| Date Received | 2015-10-20 |
| Returned To Mfg | 2015-09-16 |
| 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 | 2015-10-20 |