• 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 Detachment Of Device Component (1104); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2018
Event Type  Injury  
Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. (b)(4). The device has not been received for analysis. Upon receipt and 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 gold probe was used in a procedure performed in the mucosa on (b)(6) 2018. According to the complainant, during the procedure, the tip of the gold probe broke off and became embedded in the mucosa of the patient. 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. 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.

 
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 - SPENCER
780 brookside drive
propark free zone
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7537005
MDR Text Key109013807
Report Number3005099803-2018-01621
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,Followup
Report Date 05/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/22/2019
Device MODEL NumberM00560150
Device Catalogue Number6015
Device LOT Number20321144
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/27/2017
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: 05/23/2018 Patient Sequence Number: 1
-
-