EKSO EKSO GT NA

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number3009495988-2015-00006
MDR Report Key5168016
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2015-10-20
Date of Report2015-10-19
Date of Event2015-09-15
Date Mfgr Received2015-09-16
Device Manufacturer Date2014-12-01
Date Added to Maude2015-10-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DOUG HUMPHREY
Manufacturer Street1414 HARBOUR WAY S STE 1201
Manufacturer CityRICHMOND CA 94804
Manufacturer CountryUS
Manufacturer Postal94804
Manufacturer Phone5109841761
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEKSO
Product CodePHL
Date Received2015-10-20
Returned To Mfg2015-09-16
Model NumberEKSO GT
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No0
Device Event Key0
ManufacturerEKSO BIONICS, INC.
Manufacturer AddressRICHMOND CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-10-20

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