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

Model Number FG-0202

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Event Description

Patient undergoing a hysteroscopic myomectomy.Per the surgeon, the symphion resection device was prepared.There was a pressure sensor failure.The "pressure too high" warning kept coming on the screen.Troubleshooting included following machine instructions, powering down the generator, replacing the kit twice and calling the rep to talk the or team through the process with no success.The devices were unable to get to priming stage.The case was completed by using the bovie to dissect the uterine fibroids.No patient harm.3 reports are being submitted related to each of the three symphion fluid management accessories that were used during the case.All 3 of the symphion fluid management accessories have the same udi, gtin, lot # and expiration date.The same symphion controller was used with all three devices.This report is associated with symphion fluid management accessories device #3.Manufacturer response for insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar, symphion (per site reporter).The company rep was contacted during the case and tried to assist with troubleshooting with no success.

• Brand Name: SYMPHION
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12539919
• MDR Text Key: 273591442
• Report Number: 12539919
• Device Sequence Number: 1
• Product Code: PGT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-0202
• Device Catalogue Number: FG-0202
• Device Lot Number: 86728402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Weight: 84