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

Model Number M00542250

Device Problems Misfire (2532); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 06/18/2021

Event Type  malfunction  

Event Description

Did an esophagogastroduodenoscopy on patient and was trying to do a control bleed, put on a speed bander onto scope and then went back down to band a varices, doctor tried to deploy band and the bander misfired and no bands came off.We tried to deploy another one but with no luck.We pulled the scope back out took off that bander and put on another one.Went back down and second bander worked fine.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough, MA 01752
• MDR Report Key: 12369926
• MDR Text Key: 268309952
• Report Number: 12369926
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542250
• Device Lot Number: 26688830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA