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

Model Number FG-0202

Device Problem Failure to Prime (1492)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/13/2018

Event Type  malfunction  

Event Description

The patient was undergoing an operative hysteroscopy with removal of submucous myoma.The myoma was easily removed, however there was bleeding from the attachment site.The symphion (ref (b)(4), lot # 67542685) was set up, ready to proceed but they could not get the tubing to prime.The patient began bleeding more heavily and the circulating nurse contacted the device rep who stated they were experiencing an equipment failure and instructed them to replace the device and try again.The surgeon instead chose to use an operative hysteroscope using glycine for distending medium and a wire loop.The surgery was subsequently completed.Per the surgeon, other than the equipment failure, there were no complications related to the procedure and patient was taken to recovery room in stable condition.Estimated blood loss: 350 cc.Manufacturer response for insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar, symphion (per site reporter).The rep instructed the operation room staff to send the device back to the company for reimbursement.

• Brand Name: SYMPHION
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAG
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7929511
• MDR Text Key: 122510110
• Report Number: 7929511
• Device Sequence Number: 0
• Product Code: PGT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FG-0202
• Device Lot Number: 67542685
• 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: 09/26/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Weight: 86