MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-18 for TM-400 manufactured by Ito Co., Ltd. Tsukuba Factory.
[65565855]
The subject device was discarded at the event site. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[65565856]
During a procedure, the traction rope of the subject tm-400 device got stuck. Even after waiting a while to try to pull out the rope, the rope was still stuck and could not be pulled out. After turning off the power and trying to resume the procedure, the rope could be reeled up and a smooth traction was resumed. When the traction power level was set from 0 to 60%, the rope got stuck instantaneously and then started traction with a high speed (a speed of 60 to 100% traction power). When the 90kg setting was selected, the rope became stuck without exception.
Patient Sequence No: 1, Text Type: D, B5
[73684965]
Ito examined the device history record for the subject tm-400 device. There were no problems observed during the manufacturing or testing noted in the dhr. The user facility did not disclose the patient's information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614750-2017-00003 |
| MDR Report Key | 6261009 |
| Date Received | 2017-01-18 |
| Date of Report | 2017-01-18 |
| Date of Event | 2016-03-14 |
| Date Mfgr Received | 2016-03-14 |
| Device Manufacturer Date | 2015-01-23 |
| 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 |
| 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 | TM-400 |
| Generic Name | EQUIPMENT, TRACTION, POWERED |
| Product Code | ITH |
| Date Received | 2017-01-18 |
| Model Number | TM-400 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |