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

Model Number FG-0201

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)

Patient Problem Perforation (2001)

Event Date 06/14/2019

Event Type  Injury  

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 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
• 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 1242
• Manufacturer (Section G): SMC COSTA RICA; edificio b48 avenida 0; ,; zona franca coyol, alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 8769212
• MDR Text Key: 150370247
• Report Number: 3005099803-2019-03488
• Device Sequence Number: 1
• Product Code: PGT
• UDI-Device Identifier: 08714729863656
• UDI-Public: 08714729863656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR