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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - SPENCER TRUETOME¿ JAG 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00583140
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/20/2017
Event Type  malfunction  
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 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.
 
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Brand Name
TRUETOME¿ JAG 44
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6964632
MDR Text Key90665915
Report Number3005099803-2017-03126
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729858683
UDI-Public08714729858683
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Expiration Date06/14/2019
Device Model NumberM00583140
Device Lot Number20765470
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/22/2017
Initial Date FDA Received10/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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