MAUDE Adverse Event Report: DREAMTOME¿ RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584040

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the 28 events reported under exemption number e2012064, 21 complaint devices were returned, 6 complaint devices were disposed, and 1 complaint device was not returned.15 events were found to have the root cause of operational context, 1 event was found to have a root cause of handling, and 1 event was found to have a root cause of manufacturing.Investigation is still in place for 4 events.

Event Description

The manufacturer report is being sent as a requirement under summary reporting exemption approval number - e2012064 for product code kns.This report covers 28 reported events of tome wire and needle knife wire breaks.Of the events, 6 patients were female and 2 were male.The known patients' ages ranged from 53 years to 84 years.The known patients' weights ranged from 45 kg to 62 kg.All other demographic information is unknown.

• Brand Name: DREAMTOME¿ RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7228574
• MDR Text Key: 98734399
• Report Number: 3005099803-2018-00228
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Device Operator: No Information
• Device Model Number: M00584040
• Device Catalogue Number: 8404
• Type of Device Usage: N
• Patient Sequence Number: 1