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 40 events reported under exemption number e2012064, 21 complaint devices were returned, 14 complaints devices were disposed, and 5 complaint devices were not returned.Fifteen events were found to have a root cause of operational context.Investigation is still in place for 6 events.

Event Description

The manufacturer report is being sent as a requirement under summary reporting exemption number e2012064 for product code kns.This report covers 40 reported events of tomes and needleknives wire broken.Of the events, 4 patients were female and 5 were male.The known patients' ages ranged from 23 years to 69 years.The known patients' weights ranged from 59 kg to 64 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: 7464958
• MDR Text Key: 106841814
• Report Number: 3005099803-2018-01424
• 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: 03/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: M00584040
• Device Catalogue Number: 8404
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2018
• Type of Device Usage: N
• Patient Sequence Number: 1