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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device was disposed and 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
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion resecting device used in a hysteroscopy procedure performed on (b)(6) 2018.According to the complainant, during procedure and inside the patient, the resecting device was used to do an endometrial sampling and noticed that there was a 400cc fluid loss early in the case.The physician advanced a little further with good visualization but at some point the deficit jumped to 800cc.Upon procedure closure, the physician suspected perforation and a leak into the abdomen.A laparoscopy was done and a hole was found in the uterus with a little bit of fluid in the cavity.The physician stitched it up and suctioned any fluid out from the patient.Reportedly, the physician was unsure if the perforation was caused by the symphion resecting device or the dilation at the beginning of the case.The procedure was completed using this device.There were no patient complications as a result of the event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7621710
• Report Number: 3005099803-2018-02003
• Device Sequence Number: 16567780
• Product Code: PGT
• UDI-Device Identifier: 08714729863656
• UDI-Public: 08714729863656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/31/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2018
• Device Model Number: FG-0201
• Device Lot Number: 0065074600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/20/2018
• 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: 55 YR
• Patient Weight: 66