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

Model Number FG-0202

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a symphion fluid management accessory was used during a hysteroscopy procedure performed on (b)(6) 2018.According to the complainant, during preparation, the clear sterile package of the device had a crack on the right corner.There was no damage noted on the device inside but it was suspected that it might be unsterile.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
• 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
• 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 ; 5086834015
• MDR Report Key: 8030477
• MDR Text Key: 125910644
• Report Number: 3005099803-2018-61095
• Device Sequence Number: 1
• Product Code: PGT
• UDI-Device Identifier: 08714729863717
• UDI-Public: 08714729863717
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2018
• 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