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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the stomach during a variceal banding procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the suture was broken.There was difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the stomach during a variceal banding procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the suture was broken.There was difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.***additional information received on (b)(6), 2020** it was reported that the shank assembly was broken at the handle section of the device.
 
Manufacturer Narrative
Block h6: problem code 1069 captures the reportable issue of handle broken.Block h10: investigation results received one speedband superview super 7 for analysis; however, the device returned without the ligator head.A visual examination of the trip wire noted it was partially rolled in the handle assembly, indicating that initially the handle knob could be rotated.There were marks/scratches observed on the handle assembly and shank assembly, indicating that the trip wire was not properly secured in the handle assembly slot.There was evidence that the trip wire was placed around the shank assembly where it was found broken.A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label that trip wire was not properly secured in the handle slot indicated in the step 8.Based on the condition and evaluation of the returned device, the most probable root cause is failure to follow instructions since the problem was traced to the user not following the manufacturer instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.Additional information: b5, h10 block h11: correction: d4 (expiration date).
 
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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 Key9458306
MDR Text Key189776681
Report Number3005099803-2019-06037
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 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/26/2020
Device Model NumberM00542253
Device Catalogue Number4225-40
Device Lot Number0024503047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Date Manufacturer Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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