MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number FG-0202

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

Reported event of pressure sensor failed.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a symphion fluid management accessories kit was to be used in the uterus during a hysteroscopic myomectomy procedure performed on (b)(6) 2016.According to the complainant, during preparation, the pressure sensor test failed and the controller displayed an error message instructing to "replace pressure sensor." the procedure was completed using another symphion fluid management accessories kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

One symphion fluid management accessory device was received for analysis.A functional evaluation of the device noted that it was possible for the pressure sensor connector to be inserter into the receptacle on the controller, and for the pressure sensor to physically connect to the endoscope.However, the controller displayed the following error during setup: "pressure sensor test failed.Replace pressure sensor." a review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A review of all available information failed to indicate a root cause or probable root cause for this event.

Event Description

It was reported to boston scientific corporation that a symphion fluid management accessories kit was to be used in the uterus during a hysteroscopic myomectomy procedure performed on (b)(6) 2016.According to the complainant, during preparation, the pressure sensor test failed and the controller displayed an error message instructing to "replace pressure sensor." the procedure was completed using another symphion fluid management accessories kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5689298
• MDR Text Key: 46254169
• Report Number: 3005099803-2016-01576
• Device Sequence Number: 1
• Product Code: PGT
• 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,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2017
• Device Model Number: FG-0202
• Device Lot Number: 0051634464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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