MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. STORZ; FLUID MANAGEMENT SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fluid Discharge (2686)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

The case was proceeding well, and there was no fluid deficit (minus the 100ml on floor).The intrauterine tissue removal portion of the case was started and it was noted that the amount of positive deficit (meaning more fluid than less) was noted to climb steadily.The patient was stable and there were no concern from doctor as the fluid was clear with only a hint of blood noted in fluid.The circulator continued to monitor and keep surgeon informed.The intake and output noted via observation and calculation showed there was no additional fluid.At that point, a scale was obtained and all fluids were weighed and it was calculated that there was a 300ml deficit and not an addition of fluid.A work order was put in to have the fluid management system checked and calibrated.

• Brand Name: STORZ
• Type of Device: FLUID MANAGEMENT SYSTEM
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245 501
• MDR Report Key: 4489968
• MDR Text Key: 21237391
• Report Number: 4489968
• Device Sequence Number: 1
• Product Code: LTA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/18/2014

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: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2014
• Patient Sequence Number: 1
• Patient Age: 29 YR