MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY AMERICA INC FLUID MANAGEMENT TOWER; FLUID MANAGEMENT STAND

Model Number VAL17578/17579

Device Problem Inability to Irrigate (1337)

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

Event Date 12/13/2019

Event Type  malfunction  

Event Description

Storz hysteroscopic fluid management tower failed to irrigate/ flow correctly.

• Brand Name: FLUID MANAGEMENT TOWER
• Type of Device: FLUID MANAGEMENT STAND
• Manufacturer (Section D): KARL STORZ ENDOSCOPY AMERICA INC; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 10074429
• MDR Text Key: 191552105
• Report Number: 10074429
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/24/2020

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: Health Professional
• Device Model Number: VAL17578/17579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA