MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION A CORD

Model Number MH-969

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

Olympus medical systems corp (omsc) was informed that during polypectomy of colon the doctor got an error trying to activate output while he snared the target polyp and output could not be activated.Then he noticed that the subject product broke.He exchanged the subject product and the electrosurgical unit for other devices and completed the procedure.There was no repair of patient injury regarding this report.

Manufacturer Narrative

The subject device was returned to omsc for investigation.The investigation confirmed that the cable broke near a code plug.The cable core was burnt and the broken out section was discolored.Omsc was informed that the user facility had used the subject device for nearly 10 years.Omsc assumes that bending load was put on the cable repeatedly over long periods and it caused the breakage of the cable core.In addition, the user facility continued to use the subject device with the cable core broken, it caused this event.This report is being submitted as a medical devic report in an abundance of caution.

• Brand Name: A CORD
• Type of Device: A CORD
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 12-8 507; JA 12-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 3958438
• MDR Text Key: 4556638
• Report Number: 8010047-2014-00310
• Device Sequence Number: 1
• Product Code: FFZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MH-969
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1