MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE SYMPHION¿ TISSUE REMOVAL SYSTEM REFURBISHED CONTROLLER; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number FG-0612-R

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation revealed that corrosion was found on the motor board near the hand piece motor circuit.It appeared saline had dripped into the unit where the top cover meets the front bezel and created an electrical short on the main board.The short activated the motor circuits and thus the resecting device triggered by itself.Given the event description and condition of the returned device, the cause was traced back to component failure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a symphion controller was used during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure and outside the patient, the symphion resecting device started resecting immediately after connecting it into the symphion controller.The resecting device was inserted through the endoscope while the resecting device was activated in order to complete the procedure.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM REFURBISHED CONTROLLER
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7773665
• MDR Text Key: 116867748
• Report Number: 3005099803-2018-02536
• Device Sequence Number: 1
• Product Code: PGT
• UDI-Device Identifier: 08714729897279
• UDI-Public: 08714729897279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-0612-R
• Device Lot Number: MC-0069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1