MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYMPHION FLUID MANAGEMENT ACCESSORIES; INSULFFLATOR HYSTEROSCOPIC FLUID, CLOSED-LOOP

Model Number FG-0202

Device Problem Component Incompatible (1108)

Patient Problem No Information (3190)

Event Date 03/08/2018

Event Type  malfunction  

Event Description

Symphion disposables not recognized by machine.Advised this has been an issue with certain lot numbers.

• Brand Name: SYMPHION FLUID MANAGEMENT ACCESSORIES
• Type of Device: INSULFFLATOR HYSTEROSCOPIC FLUID, CLOSED-LOOP
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 7330406
• MDR Text Key: 102208490
• Report Number: MW5075794
• Device Sequence Number: 1
• Product Code: PGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/08/2018
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 12/15/2018
• Device Model Number: FG-0202
• Device Catalogue Number: FG-0202
• Device Lot Number: 64091864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 78