MAUDE Adverse Event Report: STRYKER INSTRUMENTS,DIV OF STRYKER CORP FLUIDSAFE FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Model Number 080CE 657

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/08/2014

Event Type  malfunction  

Event Description

Unit noted to be malfunctioning during procedure.Fluid deficit amount reported by machine noted to be inaccurate when compared to amount of fluid used.Machine alarming that fluid bag not connected when it was.Calculations done manually.Unit removed from service.Manufacturer to evaluate unit and provide report to facility.

• Brand Name: FLUIDSAFE FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): STRYKER INSTRUMENTS,DIV OF STRYKER CORP; 4100 east milham ave; kalamazoo MI 49001
• MDR Report Key: 3889981
• MDR Text Key: 4674410
• Report Number: 3889981
• Device Sequence Number: 1
• Product Code: HIG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2014

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: Physician
• Device Model Number: 080CE 657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/24/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2014
• Patient Sequence Number: 1
• Treatment: HYSTEROSCOPY INSTRUMENTS
• Patient Age: 51 YR