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 Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; 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 Description

It was reported to boston scientific corporation that symphion controller was used in a procedure performed on (b)(6) 2020.According to the complainant, the unit had burning smell.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: device problem code 1198 captures the reportable event of electrical problem.Block h10:investigation result a symphion controller was returned for evaluation.Based on a thorough review of the complaint, during testing the pump motor failed, also found corrosion on the motor pcba inside the console.The reported complaint of electrical issue was confirmed.The electrical issue was most likely caused by saline getting on the motor board and that electrical fault with the motor pcba.It damaged the circuitry resulting with an electrical fault and causing the reported burning smell.The evidence from the product investigation did not identify a potential product quality issue or any new patient harm.Therefore, the most probable conclusion code for this complaint is cause traced to component failure.

Event Description

It was reported to boston scientific corporation that symphion controller was used in a procedure performed on (b)(6) 2020.According to the complainant, the unit had burning smell.There were no patient complications reported as a result of this event.

• 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: 10553108
• MDR Text Key: 207533597
• Report Number: 3005099803-2020-04012
• 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: 10/20/2020

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
• Device Lot Number: MC-0226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/20/2020
• Patient Sequence Number: 1