MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRUETOME¿ JAG 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00583140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the cutting wire was broken at the tip, kinked and blackened.The investigation concluded that the complaint issue of cutting wire broken was confirmed.It is most likely that a peak voltage during the procedure could cause the failures noted; therefore, the most probable root cause of this complaint is operational context due to anatomical/procedural factors encountered during the procedure.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a truetome¿ jag 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the cut wire broke.No part of the device detached and fell inside the patient.The procedure was completed with another truetome¿ jag 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: TRUETOME¿ JAG 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6964632
• Report Number: 3005099803-2017-03126
• Device Sequence Number: 19155280
• Product Code: KNS
• UDI-Device Identifier: 08714729858683
• UDI-Public: 08714729858683
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: 06/14/2019
• Device Model Number: M00583140
• Device Lot Number: 20765470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1