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

Model Number 26602EQ

Device Problems Incorrect Measurement (1383); Device Operates Differently Than Expected (2913)

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

Event Date 04/09/2014

Event Type  malfunction  

Event Description

Patient with diagnosis of menorrhagia was undergoing a hysteroscopic resection of fibroid.The patient was brought into the operating room.Her cervix was visualized and sequentially dilated to allow the operative hysteroscope.The hysteroscope was introduced into the cavity.Deficit in the karl storz fluid management system was increasing throughout the case.When checking all the connections, the pole fell down that was holding the cannisters.This was felt to be the reason they were not getting accurate measurements.Using the morcellator device, the fibroid was removed.During the case, once it was determined that the karl storz fluid management system wasn't functioning properly, fluid was manually measured.When the deficit had reached 800 milliters of sodium chloride, the surgeon completed resecting.The instruments were removed.Good hemostatsis was noted.The patient was then transferred to recovery room in good condition.

• Brand Name: KARL STORZ
• Type of Device: FLUID MANAGEMENT SYSTEM
• Manufacturer (Section D): KARL STORZ ENDOSCOPY AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 4005040
• MDR Text Key: 18293958
• Report Number: 4005040
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/17/2014

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: Unknown
• Device Model Number: 26602EQ
• Device Catalogue Number: 20302120
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR