MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7 BAND LIGATOR; LIGATOR, ESOPHAGEAL

Catalog Number M00542251

Device Problem Misfire (2532)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Speedband superview super 7 band ligator "misfired" bands failing to ligate varices.Fda safety report id # (b)(4).

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7 BAND LIGATOR
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13019571
• MDR Text Key: 282402528
• Report Number: MW5106098
• Device Sequence Number: 3
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/14/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: M00542251
• Device Lot Number: 27036359
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1