SYMPHION FG-0201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for SYMPHION FG-0201 manufactured by Boston Scientific Corporation.

Event Text Entries

[145975338] I do not know if the device caused/contributed to potential injury, but feel it is important to consider all factors involved in the adverse event this patient suffered. My patient experienced severe bronchospasm during surgery that could be entirely unrelated to the device being used. However, it is important to consider whether any new surgical device or treatment could increase the risk of anesthesia related complications such as bronchospasm. The device is a bipolar hysteroscopic tissue resection instrument that withdraws the tissue fragments and distension media, 0. 9 normal saline, filters the tissue out along with any other particulate matter through a 40-micron filter unit before returning the distention media back to the circulation. During hysteroscopic tissue resection, it is possible for the distention media to enter the systemic circulation of the patient raising the possibility that some molecular agent precipitated the bronchospasm this patient has suffered. It is important to understand that a bronchospasm such as this can occur with any general anesthetic and surgical procedure and there is no indication that the device and the actual type of procedure being performed cause her bronchospasm.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8636143
• MDR Report Key: 8636143
• Date Received: 2019-05-23
• Date of Report: 2019-05-01
• Date of Event: 2019-03-21
• Report Date: 2019-05-01
• Date Reported to FDA: 2019-05-01
• Date Reported to Mfgr: 2019-05-23
• Date Added to Maude: 2019-05-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SYMPHION
• Generic Name: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Product Code: PGT
• Date Received: 2019-05-23
• Model Number: FG-0201
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC CORPORATION
• Manufacturer Address: 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-05-23