MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) GOLD PROBE¿; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00560070

Device Problem Arcing (2583)

Patient Problem Bowel Burn (1756)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) probe sparked.Although expected, the device at issue in this complaint has not yet been received for evaluation; therefore, a failure analysis is not available.At this time, we are unable to determine the relationship between the device and the cause for this event.If there is any further relevant information received, a supplemental medwatch report will be filed.

Event Description

It was reported to boston scientific corporation that a gold probe device was used during a procedure to treat an arteriovenous malformation (avm) in a patient's small bowel on (b)(6) 2015.According to the complainant, during the procedure the gold probe sparked when the physician tried to perform coagulation.The spark burned the patient.The physician completed the procedure using two clips.There were no other patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: GOLD PROBE¿
• Type of Device: UNIT, 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 Key: 5181858
• MDR Text Key: 29401167
• Report Number: 3005099803-2015-02997
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2017
• Device Model Number: M00560070
• Device Catalogue Number: 6007
• Device Lot Number: 17992100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other