MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC CUTTING LOOP

Model Number 880213

Device Problem Peeled/Delaminated (1454)

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

Event Date 11/28/2017

Event Type  malfunction  

Event Description

Insulation on cutting loop is peeling and flaking off during use.

• Brand Name: BOSTON SCIENTIFIC CUTTING LOOP
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 7078710
• MDR Text Key: 93807915
• Report Number: MW5073690
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2017

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: 880213
• Device Lot Number: 0717010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 33