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

Patient Problems Burn(s) (1757); Injury (2348); Burn, Thermal (2530)

Event Date 07/19/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, during an arthroscopic decompression procedure conducted by a physiotherapist, the subject device burned a point on the patient's right shoulder.

Manufacturer Narrative

Ito examined the device history record for the device involved in the adverse event.There were no problems observed during the manufacturing or testing noted in the dhr.Upon receipt of the subject device, ito conducted a failure analysis of the returned device.Ito conducted the following inspections on the returned device: appearance test: passed the pre-defined criteria.Withstand voltage test: passed the pre-defined criteria.Measurement of current leakage: 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 output voltage waveform: within the pre-defined specifications.Measurement of protective earth resistance: within the pre-defined specifications.Electrostimulation section safety device test: passed the pre-defined criteria.Measurement of ultrasound output: within the pre-defined specifications.Ultrasound section safety device test: passed the pre-defined criteria.Auto contact function test: passed the pre-defined criteria.Buzzer function test: passed the pre-defined criteria.Fan motor function test: passed the pre-defined criteria.Impact test: passed the pre-defined criteria.Ito saved all the data in the investigation file on the subject device (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 user facility did not disclose the patient's identifier.

• 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: 6311239
• MDR Text Key: 66803239
• Report Number: 9614750-2017-00006
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K071137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physical Therapist
• Device Model Number: ME940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2010
• 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: 66 YR
• Patient Weight: 63