MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) SYMPHION¿ TISSUE REMOVAL SYSTEM CONTROLLER; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number FG-0612

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2016

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a symphion controller was to be used on (b)(6) 2016.According to the complainant, during setup prior to a procedure, the controller displayed an error message indicating the pressure sensor of the fluid management accessories was faulty.The user replaced the fluid management accessories, but the same error message recurred.The user replaced the controller, reattached the previous fluid management accessories device, and setup was successfully completed.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM CONTROLLER
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5811833
• MDR Text Key: 50084268
• Report Number: 3005099803-2016-02122
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2016

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 Model Number: FG-0612
• Device Lot Number: MC-0135
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1