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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, ESOPHAGEAL Back to Search Results
Model Number M00542250
Device Problems Defective Device (2588); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2019
Event Type  malfunction  
Event Description
Performing an esophagogastroduodenoscopy with esophageal varices banding on a patient, when the speedband (multiple band ligator) did not work.It did not deploy bands despite of several attempts.The second speedband that we opened was also defective.This time it deployed 3 bands but then stopped deploying on the 4th band.Because of the defective bands, the physician decided to stop banding.Incident reported to assistant manager.First device used: speedband superview super 7 (multiple band ligator).Manufactured by boston scientific.Ref# m00542250, lot # 24234603, expiration date: 08/07/2020.Problem encountered: did not deploy the bands despite of several attempts second device used: speedband superview super 7 (multiple band ligator).Manufactured by boston scientific.Ref# m00542250, lot# 24611740, expiration date: 10/16/2020.Problem encountered: deployed 3 bands but stopped working, did not deploy the 4th band.
 
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Brand Name
SPEEDBAND SUPERVIEW SUPER 7
Type of Device
LIGATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key9450501
MDR Text Key170287734
Report Number9450501
Device Sequence Number1
Product Code MND
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00542250
Device Catalogue NumberM00542250
Device Lot Number24234603
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2019
Event Location Hospital
Date Report to Manufacturer12/11/2019
Type of Device Usage N
Patient Sequence Number1
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