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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) TRUETOME¿ JAG 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00583100
Device Problems Wire (430); Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2017
Event Type  Malfunction  
Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18. 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). According to the complainant, the suspect device was contaminated and is not available for return. If any further relevant information is received, a supplement mdr will be filed.

 
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 nurse tried to pull the device handle in order the bow the truetome¿ jag 44 and cut the papilla. At this time, it was noticed that the cutting wire dislodged from the catheter. The procedure was completed with a different device. 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 stable.

 
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Brand NameTRUETOME¿ JAG 44
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7141515
MDR Text Key96042282
Report Number3005099803-2017-03884
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
PMA/PMN NumberK122203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 11/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberM00583100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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