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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, HEMORRHOIDAL
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BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, HEMORRHOIDAL Back to Search Results
Model Number M00542253
Device Problem Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an endoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device would not deploy off the bands.After about 2 or 3 failed attempts, the device began deploying the bands.The same issue occurred with the second speedband superview super 7 device, and the procedure was completed with another speedband superview super 7device.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an endoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device would not deploy off the bands.After about 2 or 3 failed attempts, the device began deploying the bands.The same issue occurred with the second speedband superview super 7 device, and the procedure was completed with another speedband superview super 7device.There were no patient complications reported as a result of this event.Additional information received on august 27, 2019 it was reported that the problem occurred outside the patient.There was no difficulty experienced upon setting up the device.
 
Manufacturer Narrative
Block h6: problem code 2610 for the reportable issue of bands failed to deploy: conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Additional information: b5 (describe event or problem).
 
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Brand Name
SPEEDBAND SUPERVIEW SUPER 7
Type of Device
LIGATOR, HEMORRHOIDAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8916000
MDR Text Key155064885
Report Number3005099803-2019-04203
Device Sequence Number1
Product Code FHN
UDI-Device Identifier08714729504832
UDI-Public08714729504832
Combination Product (y/n)N
PMA/PMN Number
510K EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/28/2020
Device Model NumberM00542253
Device Catalogue Number4225-40
Device Lot Number0023708553
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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