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

Model Number	M00573100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The device has not been received for analysis.Upon receipt and 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 ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, after the tome was bowed, it failed to return to the unbowed position.Additionally, it was reported that when bowed, the tome was not bowing in the intended plane.The procedure was completed with a second jagtome rx 39.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event (b)(4).Visual analysis of the returned device revealed no visual damage or defects.Functionally, the unit bowed more than 90 degrees outside and inside of the scope.When the device was introduced inside the duodenoscope, the initial tip plane was found within specifications; consequently, not confirming the reported complaint.Based on all compiled information on this investigation, the most probable cause is no problem detected since the complaint included a returned device review 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 ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, after the tome was bowed, it failed to return to the unbowed position.Additionally, it was reported that when bowed, the tome was not bowing in the intended plane.The procedure was completed with a second jagtome rx 39.There were no patient complications reported as a result of this event.

• 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: 8518068
• Report Number: 3005099803-2019-01949
• Device Sequence Number: 19294267
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: 08714729776536
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/17/2019

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: 01/02/2022
• Device Model Number: M00573100
• Device Catalogue Number: 7310
• Device Lot Number: 0023136949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1