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

Model Number M00560070

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported event of gold probe failed to cauterize.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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a gold probe¿ was used on an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the gold probe failed to cauterize when it made contact with the mucosa.The procedure was completed using the same generator and generator settings with another gold probe.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

A visual evaluation of the returned device found no visible failures.An electrical load test was performed and the device tested to be within specification.Based on all gathered information and investigation results, there is no evidence of either the alleged issue or any defect which could have contributed to the event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that a gold probe¿ was used on an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the gold probe failed to cauterize when it made contact with the mucosa.The procedure was completed using the same generator and generator settings with another gold probe.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 6082867
• MDR Text Key: 59335386
• Report Number: 3005099803-2016-03237
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2018
• Device Model Number: M00560070
• Device Catalogue Number: 6007
• Device Lot Number: 19291961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2016
• 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