MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number	FG-0202
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact age of the patient is unknown, however, it was reported the patient was over 18 years.Manufacturer: smc (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this manufacturer report pertains to one of two devices used in the same procedure.Manufacturer report # 3005099803-2017-02791 pertains to the first symphion fluid management accessory and manufacturer report # 3005099803-2017-02792 to the second symphion management accessory.It was reported to boston scientific corporation on (b)(4) 2017 that a symphion fluid management accessory device was used during a polypectomy procedure performed on (b)(6) 2017.According to the complainant, during preparation, they received a faulty pressure sensor error message (captured in mfr report # 3005099803-2017-02791).A second fluid management accessory device was used but the same thing happened (captured in mfr report # 3005099803-2017-02792).The procedure was completed with a third symphion fluid management kit.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6882028
• Report Number: 3005099803-2017-02792
• Device Sequence Number: 16439883
• Product Code: PGT
• UDI-Device Identifier: 08714729863717
• UDI-Public: 08714729863717
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: FG-0202
• Device Lot Number: 0059242129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1