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

Model Number	M00573040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(6).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, after rotating and manipulating the tome during the procedure, the cutting wire broke.Reportedly, no part of the device detached and fell into the patient.During removal of the device from the endoscope the physician was pricked in the finger by the broken cutting wire.The affected area was irrigated, the patient was tested for communicable diseases and facility protocols were followed.The patient does not have any known communicable diseases and the physician was wearing gloves at the time of the incident.Reportedly, the physician has no further concerns regarding this needle stick event.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: JAGTOME 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
• MDR Report Key: 10898727
• Report Number: 3005099803-2020-05721
• Device Sequence Number: 2478506
• Product Code: KNS
• UDI-Device Identifier: 08714729776659
• UDI-Public: 08714729776659
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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 Model Number: M00573040
• Device Catalogue Number: 7304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1