MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPEEDBAND SUPERVIEW SUPER 7¿; LIGATOR, HEMORRHOIDAL

Model Number M00542251

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

This manufacturer report pertains to one of four devices used in the same procedure.Manufacturer report #3005099803-2017-02888 pertains to the first speedband superview super 7 device, manufacturer report #3005099803-2017-02889 pertains to the second speedband superview super 7 device, manufacturer report #3005099803-2017-02890 pertains to the third speedband superview super 7 device and manufacturer report #3005099803-2017-02891 pertains to the fourth speedband superview super 7 device.It was reported to boston scientific corporation that four speedband superview super 7 devices were used in a procedure performed on an unknown date.According to the complainant, during the procedure, the bands on all four devices misfired.The procedure was completed with another speedband device.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be fine.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7¿
• Type of Device: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6911811
• MDR Text Key: 88158427
• Report Number: 3005099803-2017-02891
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 20515812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1