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

Model Number FG-0202

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2017

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 fluid management accessories was used during a polypectomy procedure performed on (b)(6) 2017.According to the complainant, during preparation, the fluid management accessories was being set-up and the pressure sensor was not detected.The scope was disconnected from the controller several times and the controller was restarted twice and the pressure sensor was still not detected.A new fluid management accessory was used with the same scope and controller and the procedure was completed.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

A symhpion device was returned for analysis.Visual analysis revealed no signs of damage to the device.Functional analysis revealed that the pressure sensor connector was possible to be inserted into the receptacle on the connector.However, the controller did not detect the pressure sensor.Therefore, the complaint was confirmed.Given the event description and condition of the returned device, there isn't enough information to determine a probable root cause.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a symphion fluid management accessories was used during a polypectomy procedure performed on (b(6) 2017.According to the complainant, during preparation, the fluid management accessories was being set-up and the pressure sensor was not detected.The scope was disconnected from the controller several times and the controller was restarted twice and the pressure sensor was still not detected.A new fluid management accessory was used with the same scope and controller and the procedure was completed.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES
• 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: 6460740
• MDR Text Key: 72097701
• Report Number: 3005099803-2017-01075
• Device Sequence Number: 1
• Product Code: PGT
• UDI-Device Identifier: 08714729863717
• UDI-Public: (01)08714729863717(11)20180102(10)0058639701
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2018
• Device Model Number: FG-0202
• Device Lot Number: 0058639701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 39 YR