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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device component code relates to device problem code for the reported event: cut wire broke.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 truetome 44 was used in a procedure on (b)(6) 2017.According to the complainant, during the procedure, the truetome 44 cutting wire broke.Reportedly, it was difficult to remove the truetome 44 from the working channel of the endoscope, so they decided to remove the endoscope and the truetome 44 together.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event has been unsuccessful to date.Should additional relevant details becomes available, a supplemental report will be submitted.

• 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: 7130138
• Report Number: 3005099803-2017-03880
• Device Sequence Number: 1824564
• Product Code: KNS
• UDI-Device Identifier: 08714729858683
• UDI-Public: 08714729858683
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

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: 05/09/2019
• Device Model Number: M00583140
• Device Lot Number: 20622177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1