ME718 US-101L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-18 for ME718 US-101L manufactured by Ito Co., Ltd. Tsukuba Factory.

Event Text Entries

[65209433] Ultrasound was applied to the patient's hip using the subject us-101l device at 100% output on 2. 00 w/cm2 with 1 mhz frequency. The application was made for one minute to one and a half minutes on each spot, and the total application time was five minutes. The electrodes were used in a stroking motion within a 2 cm width. The procedure stated to change the application spot upon any alleged discomfort or pain by a patient. There was no heat sensation alleged by the patient during the treatment. There was no blister observed after the treatment, but a blister was confirmed a few days later upon receiving a complaint from the patient.
Patient Sequence No: 1, Text Type: D, B5


[67455735] This event involving us-101l device occurred in (b)(6), but similar device is marketed in the u. S under the brand name me718.
Patient Sequence No: 1, Text Type: N, H10


[73139350] Upon receipt of the device involved in the adverse event, ito conducted a failure analysis of the returned device: ito inspected the appearance of the returned device and observed fine scratches on the surface and corrosion in the center of the oscillator. Ito conducted the following inspections on the returned device: - measurement of oscillatory frequency: within the pre-defined specifications. - measurement of power input: within the pre-defined specifications. - measurement of ultrasound output: within the pre-defined specifications. - safety equipment: functioned as pre-defined. - fan motor: functioned as pre-defined. - shock test: passed. - load test: passed. - environment test: passed. - measurement of era: within the pre-defined specifications. - measurement of bnr: within the pre-defined specifications. Ito saved all the data in the investigation report on us-101l (s/n: (b)(4)). Conclusion reached based on the investigation and analysis result: the subject device functions without any abnormality. Ito reminded the user of the correct usage, as described in the user manual. The healthcare facility did not disclose the information on the patient's weight.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9614750-2017-00002
MDR Report Key6261883
Date Received2017-01-18
Date of Report2017-02-10
Date of Event2016-01-20
Date Mfgr Received2016-02-04
Device Manufacturer Date2010-11-10
Date Added to Maude2017-01-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
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. KENNETH BLOCK
Manufacturer Street1201 RICHARDSON DR. SUITE 160
Manufacturer CityRICHARDSON TX 75080
Manufacturer CountryUS
Manufacturer Postal75080
Manufacturer Phone9724809554
Manufacturer G1ITO CO., LTD.
Manufacturer Street3-39-14 UZURANO AMI-MACHI
Manufacturer CityINASHIKI-GUN, IBARAKI 300-0341
Manufacturer CountryJA
Manufacturer Postal Code300-0341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameME718
Generic NameULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
Product CodeIMI
Date Received2017-01-18
Returned To Mfg2016-02-09
Model NumberUS-101L
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerITO CO., LTD. TSUKUBA FACTORY
Manufacturer Address3-39-14 UZURANO AMI-MACHI INASHIKI-GUN, IBARAKI 300-0341 JA 300-0341


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-01-18

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