MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2017-02-08 for SONICATOR PLUS 940 ME940 manufactured by Ito Co., Ltd. Tsukuba Factory.
[66803239]
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.
Patient Sequence No: 1, Text Type: D, B5
[72274439]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614750-2017-00006 |
| MDR Report Key | 6311239 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2017-02-08 |
| Date of Report | 2015-02-08 |
| Date of Event | 2015-07-19 |
| Date Mfgr Received | 2015-10-01 |
| Device Manufacturer Date | 2010-05-14 |
| Date Added to Maude | 2017-02-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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. TSUKUBA FACTORY |
| 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 | SONICATOR PLUS 940 |
| Generic Name | ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT |
| Product Code | IMI |
| Date Received | 2017-02-08 |
| Returned To Mfg | 2015-07-31 |
| Model Number | ME940 |
| Operator | PHYSICAL THERAPIST |
| Device Availability | R |
| 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 | 2017-02-08 |