MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGTOME¿ RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573060
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2018
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.However, the complainant stated that the device was used prior to the expiration date.(b)(4).The complainant indicated that the device has been 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 mdr will be filed.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report# 3005099803-2018-00473 for the first jagtome¿ rx 44, 3005099803-2018-00474 for the second jagtome¿ rx 44, and 3005099803-2018-00475 for the third jagtome¿ rx 44.It was reported to boston scientific corporation that three jagtome¿ rx 44 devices were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noticed that the cut wire was oriented in the wrong direction when it first exited the scope.Two more jagtome¿ rx 44 devices were used during the procedure and same thing happened.Reportedly, there was no any visible damage to these devices prior to putting it through the scope or after the issue occurred.The procedure was completed with a fourth jagtome¿ rx 44.There were no 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 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7284679
• Report Number: 3005099803-2018-00475
• Device Sequence Number: 2116613
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: 08714729776673
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/25/2018

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 Model Number: M00573060
• Device Catalogue Number: 7306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1