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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 Problems Positioning Failure (1158); Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2019
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 sigmoid colon during a flex sigmoid banding procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was defective.The procedure was completed with another speedband superview super 7 device.There were no serious injury or adverse patient effects reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the sigmoid colon during a flex sigmoid banding procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was defective.The procedure was completed with another speedband superview super 7 device.There were no serious injury or adverse patient effects reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
Block h6: problem code 2610 for the reportable issue of bands was defective.Block h10: investigation results: a speedband superview super 7 was returned with the ligator head for analysis.It was noticed that the crimp was present on the trip wire.A visual examination of the ligator head found no bands were present which indicates that bands were deployed.It was noticed that ligator head teeth were not bent nor damaged.The suture was intact and was attached to the trip wire loop.The trip wire was secured in the handle assembly.No visible issue was noted with the handle assembly and the ligator head.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.Residues were present indicating use and handling.Based on the evaluation of the returned device, the device showed neither evidence of the alleged issue nor any defect which could have contributed to the complaint.Therefore, it was concluded that the investigation conclusion code of this event is "no problem detected" since the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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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 Key8429830
MDR Text Key139113112
Report Number3005099803-2019-01293
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 04/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Model NumberM00542253
Device Catalogue Number4225-40
Device Lot Number23276596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Date Manufacturer Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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