MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMPHION; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number FG-0612

Device Problems Electrical /Electronic Property Problem (1198); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a symphion controller was used during a polypectomy procedure in the uterus performed on (b)(6) 2018.According to the complainant, during the procedure, upon connecting the resecting device into the symphion controller, the resecting device started resecting immediately without any prompt on the screen.The problem happened on three symphion resecting devices.The device was unplugged and it would not recognize the resecting device anymore that it was plugged in.The procedure was completed with another symphion controller.There were no patient serious injury or adverse effects to the patient as a result of the event.

Event Description

It was reported to boston scientific corporation on that a (b)(6) 2018 that a symphion controller was used during a polypectomy procedure in the uterus performed on (b)(6) 2018.According to the complainant, during the procedure, upon connecting the resecting device into the symphion controller, the resecting device started resecting immediately without any prompt on the screen.The problem happened on three symphion resecting devices.The device was unplugged and it would not recognize the resecting device anymore that it was plugged in.The procedure was completed with another symphion controller.There were no patient serious injury or adverse effects to the patient as a result of the event.

Manufacturer Narrative

The investigation revealed that corrosion was found on the motor board near the hand piece motor circuit.Corrosion was also found on upper case lid and main chassis.It appeared that saline had dripped into the unit where the top cover meets the front bezel.It is most likely that the saline dripped in and created an electrical short on the main board preventing proper operation of the resecting device.This confirms the complaint.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.

• Brand Name: SYMPHION
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7800703
• MDR Text Key: 117706219
• Report Number: 3005099803-2018-60074
• Device Sequence Number: 1
• Product Code: PGT
• Combination Product (y/n): N
• PMA/PMN Number: K141848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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
• Device Catalogue Number: 74076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 08/28/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1