MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00545180
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, after the handle was actuated and bowed the device to a desired position, it was noticed that the cutting wire would not release the bow despite several attempts of relaxing the wire.It was reported that the device was not energized when the problem was noticed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and shows the device in a bowed position.
Additional Manufacturer Narrative
Block h6: imdrf device code a050701captures the reportable event of wire was unable to release the bow.
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, after the handle was actuated and bowed the device to a desired position, it was noticed that the cutting wire would not release the bow despite several attempts of relaxing the wire.It was reported that the device was not energized when the problem was noticed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and shows the device in a bowed position.
Additional Manufacturer Narrative
Block h6: imdrf device code a050701captures the reportable event of wire was unable to release the bow.Block h10: the returned autotome rx 44 was analyzed, and there was no visible problem on the device was noted.A functional test was performed, and the device was able to bow and unbow inside and outside of the scope as intended.Media analysis of the photo provided by the customer showed the distal section of the device; however, the handle was not visible.Since the handle position is not visible in the photo, it cannot be determined if the handle was fully extended to confirm the device would not release the bow.No problems with the device were noted.The reported event of wire unable to release bow (unbow) was not confirmed.Upon analysis, the device bowed and returned from the bow as intended.The returned unit did not show evidence of the alleged problem or any defect that could have contributed to the event reported.Based on all gathered information, the most probable root cause of this complaint is no problem detected.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: AUTOTOME RX 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18477366
• Report Number: 3005099803-2024-00015
• Device Sequence Number: 17863843
• Product Code: KNS
• UDI-Device Identifier: 08714729444756
• UDI-Public: 08714729444756
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: 08/03/2026
• Device Model Number: M00545180
• Device Catalogue Number: 4518
• Device Lot Number: 0032155578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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