MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. OR1 ESSENTIAL NEO MID LEVEL SYSTEM 1; INTEGRATED SYSTEM

Model Number WUIS531

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

Although we have been unable to obtain further details about the procedure or patient condition, the initial report indicated there was no harm to patient.Our technician replaced a failed video router on-site.The integrated system involved is obsolete and is at end-of-life.

Event Description

Allegedly, the system in the integrated room shut down during an arthroscopic procedure, and the procedure had to be converted to an open procedure.

• Brand Name: OR1 ESSENTIAL NEO MID LEVEL SYSTEM 1
• Type of Device: INTEGRATED SYSTEM
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 13803 n. promenade blvd.; stafford TX 77477
• MDR Report Key: 12111932
• MDR Text Key: 262244184
• Report Number: 9610617-2021-00052
• Device Sequence Number: 1
• Product Code: LMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WUIS531
• Device Catalogue Number: WUIS531
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other