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.
[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
| Report Number | 9614750-2017-00002 |
| MDR Report Key | 6261883 |
| Date Received | 2017-01-18 |
| Date of Report | 2017-02-10 |
| Date of Event | 2016-01-20 |
| Date Mfgr Received | 2016-02-04 |
| Device Manufacturer Date | 2010-11-10 |
| Date Added to Maude | 2017-01-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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. KENNETH BLOCK |
| Manufacturer Street | 1201 RICHARDSON DR. SUITE 160 |
| Manufacturer City | RICHARDSON TX 75080 |
| Manufacturer Country | US |
| Manufacturer Postal | 75080 |
| Manufacturer Phone | 9724809554 |
| Manufacturer G1 | ITO CO., LTD. |
| Manufacturer Street | 3-39-14 UZURANO AMI-MACHI |
| Manufacturer City | INASHIKI-GUN, IBARAKI 300-0341 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 300-0341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ME718 |
| Generic Name | ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT |
| Product Code | IMI |
| Date Received | 2017-01-18 |
| Returned To Mfg | 2016-02-09 |
| Model Number | US-101L |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITO CO., LTD. TSUKUBA FACTORY |
| Manufacturer Address | 3-39-14 UZURANO AMI-MACHI INASHIKI-GUN, IBARAKI 300-0341 JA 300-0341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-18 |