• 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 - COSTA RICA (COYOL) INJECTION GOLD PROBE¿ 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 - COSTA RICA (COYOL) INJECTION GOLD PROBE¿ UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00560150
Device Problems Material Separation (1562); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2017
Event Type  Malfunction  
Manufacturer Narrative

(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

Note: this report pertains to the one of two complaint devices used during the same procedure. Refer to manufacturer report # 3005099803-2017-01833 for the other associated device information. It was reported to boston scientific corporation that an injection gold probe¿ was used in the esophagus or stomach during a procedure performed on (b)(6) 2017. According to the complainant, the gold probe was performing properly. The device was removed to clean some tissue particles off the tip. While cleaning it with a 4x4 gauze, the tip detached. The procedure was completed with a third injection gold probe¿. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINJECTION GOLD PROBE¿
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 Key6667748
MDR Text Key78472183
Report Number3005099803-2017-01834
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK961349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/06/2019
Device MODEL NumberM00560150
Device Catalogue Number6015
Device LOT Number20499250
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 Received06/06/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/07/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-