MAUDE Adverse Event Report: BOSTON SCIENTIFIC; RESECTOSCOPE

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2016

Event Type  malfunction  

Event Description

Electrical cord on trans urethral resection prostatectomy started smoking.

• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough, MA 01752
• MDR Report Key: 5806621
• MDR Text Key: 49920868
• Report Number: 5806621
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR