MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number	M00562652
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h10: imdrf device code a090402 captures the reportable event of energy generation issue.
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was used during a colonoscopy with polypectomy procedure performed on (b)(6)2023.During the procedure, there was no indication of electrical current being detected by the device, despite all the cords being properly connected.They went so far as to attempt using a new "red" bovie cord and replacing the grounding pad.Additionally, they tried using another bovie machine from a different room.The procedure was completed with a similar sensation large oval med stiff snare.There were no patient complications reported as a result of this event.

• Brand Name: SENSATION SHORT THROW
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17355939
• Report Number: 3005099803-2023-03749
• Device Sequence Number: 20100003
• Product Code: FDI
• UDI-Device Identifier: 08714729268802
• UDI-Public: 08714729268802
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2025
• Device Model Number: M00562652
• Device Catalogue Number: 6265-20
• Device Lot Number: 0029097842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown