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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 Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/30/2019
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 two speedband superview super 7 devices were used during an upper endoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, both bands broke off and snapped.The procedure was completed with another speedband superview super 7 device.There were no patient complications 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 two speedband superview super 7 devices were used during an upper endoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, both bands broke off and snapped.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
Problem code 1484 for the reportable issue of bands prematurely deployed.Investigation results: a speedband superview super 7 was returned with the ligator head for analysis.A visual examination of the ligator head found all bands were present with the fifth and sixth bands were moved out of their positiona nd the fifth band was caught under the other bands with no broken bands observed.It was noticed that he ligature head teeth were bent.The tripw ire was completely rolled in the handle and was secured in the handle assembly slot when received.Also, the trip wire was cut with one section of the was not returned, the cut ends of the trip wire was visually inspected under the magnification.The cut ends had marks indicating sharp tool was used to cut the trip wire.Likely the trip wire was cut to separate the device from the scope, therefore it is not considered as an issue of the device.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 Key8632426
MDR Text Key145787416
Report Number3005099803-2019-02612
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 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/09/2019
Device Model NumberM00542253
Device Catalogue Number4225-40
Device Lot Number0022914977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2019
Date Manufacturer Received06/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
Patient Weight61
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