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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION JAGTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number 47290
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 07/01/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported. The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in a procedure. According to the complainant, during the procedure, the physician noticed an unusual burn on patient during sphincterotomy. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
 
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Brand NameJAGTOME RX 44
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
propark, coyol,
alajuela
CS
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key7786799
MDR Text Key117219503
Report Number3005099803-2018-60026
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number47290
Device Catalogue Number47290
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 Received07/18/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/15/2018 Patient Sequence Number: 1
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