MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, after bowing the device a few times, the cutting wire broke.Reportedly, no part of the device detached inside the patient.The procedure was completed with a second jagtome rx 39, using the same generator and active cord used.There were no user injuries nor patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device revealed no visual defects.It looked under good conditions without evidence of damages or anomalies.The device was introduced inside the scope and the unit bowed more than 90 degrees outside and inside of the scope and the unit released the bow without problems.The complaint was not consistent with the reported event of cutting wire broke.All compiled information on this investigation determines that the most probable cause is no problem detected since the complaint included a returned device review (visual, physical, and performance testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, after bowing the device a few times, the cutting wire broke.Reportedly, no part of the device detached inside the patient.The procedure was completed with a second jagtome rx 39, using the same generator and active cord used.There were no user injuries nor patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: JAGTOME RX 39
• 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: 7979193
• Report Number: 3005099803-2018-60882
• Device Sequence Number: 19174553
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: 08714729776536
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2018

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: 01/18/2021
• Device Model Number: M00573100
• Device Catalogue Number: 47270
• Device Lot Number: 0021635088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1