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

Catalog Number 08714729201953

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/28/2020

Event Type  malfunction  

Event Description

When we were preparing to use the multiple band ligator it was noticed that the wire of the device was bent in multiple locations.Due to the bent wire we were unable to feed the wire through the scope.Fda safety report id # (b)(4).

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752
• MDR Report Key: 10372751
• MDR Text Key: 202060242
• Report Number: MW5095903
• Device Sequence Number: 1
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Catalogue Number: 08714729201953
• Device Lot Number: 25276352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 39 YR
• Patient Weight: 54