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

Model Number M00560150

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

(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 an injection gold probe¿ was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure the device failed to cauterized.The procedure was completed with another injection gold probe¿.There were no patient complications reported as a result of this event.There were no patient harm at the conclusion of the procedure.

Manufacturer Narrative

Investigation results: 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 other complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that an injection gold probe¿ was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure the device failed to cauterized.The procedure was completed with another injection gold probe¿.There were no patient complications reported as a result of this event.There were no patient harm at the conclusion of the procedure.

• Brand Name: INJECTION 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: 6684678
• MDR Text Key: 79032658
• Report Number: 3005099803-2017-01902
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)20181010(10)0019822992
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K961349
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2018
• Device Model Number: M00560150
• Device Catalogue Number: 6015
• Device Lot Number: 0019822992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• 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
• Patient Age: 82 YR