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

Model Number	FG-0202
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device has been 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) 2019 that a symphion fluid management accessory was used during a hysteroscopy with dilatation and curettage procedure performed on (b)(6) 2019.According to the complainant, during preparation, the plastic tray was cracked and the sterile package was opened.The procedure was completed with another symphion fluid management accessory.There were no serious injury/adverse effect to patient as a result of the event.

• 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
• MDR Report Key: 8317517
• Report Number: 3005099803-2019-00486
• Device Sequence Number: 16155011
• Product Code: PGT
• UDI-Device Identifier: 08714729863717
• UDI-Public: 08714729863717
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/07/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2019
• Device Model Number: FG-0202
• Device Catalogue Number: 74052
• Device Lot Number: 0069879396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1