MAUDE Adverse Event Report: ITO CO., LTD. TSUKUBA FACTORY SONICATOR PLUS 940; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number ME940

Device Problems Degraded (1153); Material Integrity Problem (2978); Physical Property Issue (3008); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Swelling (2091); Injury (2348)

Event Date 01/11/2017

Event Type  Injury  

Event Description

The patient was treated with the subject device with quadrupole interference wave at 70ma output for fifteen minutes.The patient noticed a blister on the upper abdominal area after the treatment.

Manufacturer Narrative

Upon receipt of the device involved in the adverse event, ito conducted a failure analysis of the returned device.Inspection of the main unit returned: high voltage test: passed.Measurement of leakage current: within the pre-defined specifications.Measurement of power input: within the pre-defined specifications.Measurement of output voltage: within the pre-defined specifications.Measurement of output current: within the pre-defined specifications.Measurement of frequence: within the pre-defined specifications.Measurement of protectional ground resistance: within the pre-defined specifications.Test on safety mechanism: passed.Test on over-current detection function: passed.Measurement of ultrasound output: within the pre-defined specifications.Test on led lamp: passed.Test on fan motor: passed.Test on buzzer: passed.Test on unit display: passed.Inspection of consumable accessories returned: inspection on viscosity of the electrode surface: deterioration observed.Conclusion: ito concluded based on the analysis that the electrodes with deteriorated surface may have resulted in the concentration of electric current, which caused the patient's burn.In order to prevent the recurrence, ito reminded the user to follow the instruction for use contained in the user manual including the replacement of electrodes before deterioration of the surface.

• Brand Name: SONICATOR PLUS 940
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, 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. TSUKUBA FACTORY; 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: 6462422
• MDR Text Key: 71830091
• Report Number: 9614750-2017-00008
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ME940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2011
• 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: 53 YR
• Patient Weight: 54