MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OR1 NEO IP, ENH; NEO IP CONTROLLER

Model Number WUIS2546-01

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

Our onsite technician was unable to reproduce the issue, and reported that the site did have a grounding issue on a 120v receptacle in this room that has since been repaired after incident.Cause is unknown as we were unable to replicate the issue.Since the esu is a rolling unit, the site has been instructed to isolate the machine to include all cables and unit for further extensive testing if the problem occurs again.

Event Description

Customer reported that when triggering the esu-erbe vio 300d, the olympus cv-190 camera image would go black when routed to any monitor/display, including vitals.The patient needed to be moved to a different room and surgeon was able to complete the procedure; there was no negative patient impact.

• Brand Name: OR1 NEO IP, ENH
• Type of Device: NEO IP CONTROLLER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15085241
• MDR Text Key: 296595040
• Report Number: 9610617-2022-00129
• Device Sequence Number: 1
• Product Code: LMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WUIS2546-01
• Device Catalogue Number: WUIS2546-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• 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