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

Model Number	FG-0201
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Pressure Problem (3012)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; 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 or Problem Description
This manufacturer report pertains to one of two symphion resecting devices that were used on the same procedure.It was reported to boston scientific corporation on (b)(6) 2019 that two symphion resecting device was used for a polypectomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, an error was received stating low pressure detected, resection on hold and it was noted that there was saline leaking from the patient.The device was changed to another symphion resecting device since it was thought that there was a device malfunction due to the error.The second device was used and there was more saline noted that was flowing out from the patient.The physician was able to successfully resect, however it was noted that there less return flow of saline and there was a total deficit of 2,200 ml.A laparoscopy procedure was needed and it revealed a lot of saline was in the belly of the patient.The physician suspected possible perforation but successfully completed the procedure after the saline in the belly was removed.

• Brand Name: SYMPHION
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8769212
• Report Number: 3005099803-2019-03488
• Device Sequence Number: 2038694
• Product Code: PGT
• UDI-Device Identifier: 08714729863656
• UDI-Public: 08714729863656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2019
• Device Model Number: FG-0201
• Device Catalogue Number: 74080
• Device Lot Number: 0072114630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR