MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; 24F CUTTING LOOP

Model Number 0068802030

Device Problems Break (1069); Thermal Decomposition of Device (1071); Charred (1086); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2016

Event Type  malfunction  

Event Description

During a transuretheral resection on bladder tumor, electro surgical loop electrode and cystoscopy lens inserted via resectoscope, surgeon could not visualize.They were removed and inspected.Findings; electrode wire appeared to have melted resulting in a break of the wire and charring on the wire.The lens was badly damaged with burn marks from the electrode at the end of the lens.A replacement electrode and lens were used by the surgeon to inspect the patient's bladder.No injury was noted to the bladder.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: 24F CUTTING LOOP
• Manufacturer (Section D): BOSTON SCIENTIFIC; 780 brookside drive; arden hills MN
• MDR Report Key: 5900659
• MDR Text Key: 52993016
• Report Number: MW5064296
• Device Sequence Number: 1
• Product Code: FAS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/19/2016

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: Health Professional
• Device Model Number: 0068802030
• Device Lot Number: 1215005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 86