MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMPHION; 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 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 on november 4, 2019 that a symphion controller was used in a dilation and curettage (d and c) procedure performed on (b)(6) 2019.According to the complainant, when they plugged in the resecting device into the controller the device started resecting and reciprocating on its own.The procedure was aborted due to this event.There were no patient safety issues reported as a result of this event.

Event Description

It was reported to boston scientific corporation on november 4, 2019 that a symphion controller was used in a dilation and curettage (d and c) procedure performed on (b)(6), 2019.According to the complainant, when they plugged in the resecting device into the controller the device started resecting and reciprocating on its own.The procedure was aborted due to this event.There were no patient safety issues reported as a result of this event.

Manufacturer Narrative

Block h6: problem code 1198 captures the reportable event of electrical/electronic property problem.Block h10:investigation result a symphion controller was returned for evaluation.Based on a thorough review of the complaint, they found an intermittent operation with the returned footswitch.The footswitch cable was pullin out of the male plug connector, also found corrosion on the motor pcba inside the console.The reported complaint of electrical issue was confirmed.The fault was most likely caused by unintended mishandling of the footswitch connector causing physical damage to the connector.Therefore, the most probable cause for this complaint is unintended use error caused or contributed to event which indicates that the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.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: 9341891
• MDR Text Key: 186020521
• Report Number: 3005099803-2019-05664
• Device Sequence Number: 1
• Product Code: PGT
• UDI-Device Identifier: 08714729897279
• UDI-Public: 08714729897279
• 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: 03/23/2020

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 Catalogue Number: 74076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1