• Decrease font size
  • Return font size to normal
  • Increase font size
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)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION JAGTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00573550
Device Problem Break (1069)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/02/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon 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 Description

It was reported to boston scientific corporation that a jagtome rx 44 was manipulated by the nurse on (b)(6) 2018. According to the complainant, the nurse was manipulating the tome and was pricked on his finger by the cutting wire which appeared broken. An emergency (b)(6) booster was given to the nurse. Reportedly, there was no patient involvement in the event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJAGTOME RX 44
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 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 Key7844723
MDR Text Key119148026
Report Number3005099803-2018-60279
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM00573550
Device Catalogue Number47290
Device LOT Number0021818225
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/18/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/05/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/04/2018 Patient Sequence Number: 1
-
-