MAUDE Adverse Event Report: ITO CO., LTD. TSUKUBA FACTORY ME718; ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number US-101L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Date 01/20/2016

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

This event involving us-101l device occurred in (b)(6), but similar device is marketed in the u.S under the brand name me718.

Manufacturer Narrative

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.

• Brand Name: ME718
• Type of Device: ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): ITO CO., LTD. TSUKUBA FACTORY; 3-39-14 uzurano; ami-machi; inashiki-gun, ibaraki 300-0 341; JA 300-0341
• Manufacturer (Section G): ITO CO., LTD.; 3-39-14 uzurano; ami-machi; inashiki-gun, ibaraki 300-0 341; JA 300-0341
• Manufacturer Contact: kenneth block ; 1201 richardson dr.; suite 160; richardson, TX 75080 ; 9724809554
• MDR Report Key: 6261883
• MDR Text Key: 65209433
• Report Number: 9614750-2017-00002
• Device Sequence Number: 1
• Product Code: IMI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: US-101L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR