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

Model Number FG-0201

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

Although expected, the device at issue in this complaint has not yet been received for evaluation; therefore, a failure analysis is not available.At this time, we are unable to determine the relationship between the device and the cause for this event.If there is any further relevant information received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a symphion resecting device was used in the uterus during a hysteroscopy with dilation, curettage and myomectomy procedure performed on (b)(6) 2016.According to the complainant, during the procedure and upon activation of the resection footswitch, the resecting device failed to reciprocate and the device emitted excessive bubbling within the uterine cavity.The user also smelled a metallic and/or plastic burning smell and noted that there was no fluid exiting the resecting device through the outflow tubing.The procedure was continued using another symphion resecting device and fluid management accessories kit; however, the procedure was not completed as the maximum amount of saline had been utilized during the case.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 fine.

Manufacturer Narrative

One symphion resecting device was received for analysis.A visual examination of the device noted that the electrode was charred, which is expected during normal usage and indicates the device was activated.A functional evaluation revealed that the resecting device connect could be inserted into the symphion controller receptacle; however, the controller did not detect the device.Further evaluation of the device's electrode revealed that the electrode was outside of the proper position, preventing the device from being detected by the controller.After the device's electrode was manually reset, the device could connect to the controller, resect, and coagulate as expected.No burning smell was noted during testing.The investigation of the returned device could not confirm the complaint.The investigation concluded that the condition of the returned device indicated that the device functioned for some time, but may have stopped while the electrode was out of position.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 search of the complaint database confirmed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a symphion resecting device was used in the uterus during a hysteroscopy with dilation, curettage and myomectomy procedure performed on (b)(6) 2016.According to the complainant, during the procedure and upon activation of the resection footswitch, the resecting device failed to reciprocate and the device emitted excessive bubbling within the uterine cavity.The user also smelled a metallic and/or plastic burning smell and noted that there was no fluid exiting the resecting device through the outflow tubing.The procedure was continued using another symphion resecting device and fluid management accessories kit; however, the procedure was not completed as the maximum amount of saline had been utilized during the case.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 fine.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE
• 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: 5742739
• MDR Text Key: 47965257
• Report Number: 3005099803-2016-01852
• 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: 05/27/2016

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: 06/02/2016
• Device Model Number: FG-0201
• Device Lot Number: 0044743182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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