MAUDE Adverse Event Report: ITO CO., LTD. TSUKUBA FACTORY TM-400; EQUIPMENT, TRACTION, POWERED

Model Number TM-400

Device Problems Difficult to Remove (1528); Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was discarded at the event site.Device not returned to manufacturer.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: TM-400
• Type of Device: EQUIPMENT, TRACTION, POWERED
• 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: 6261009
• MDR Text Key: 65565855
• Report Number: 9614750-2017-00003
• Device Sequence Number: 1
• Product Code: ITH
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K081247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TM-400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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