MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OR1 NEO IP, ENH2; NEO IP CONTROLLER

Model Number WUIS2548

Device Problem Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/24/2022

Event Type  Injury  

Event Description

Customer reported a ups overheating alarm on the integration rack, and when the biomed was inspecting the equipment, he reached across the back of the equipment on the rack and received a 2nd degree burn on his arm.

Manufacturer Narrative

The equipment will be inspected onsite, and a supplement report will be submitted when further information becomes available.

Manufacturer Narrative

Our technician was unable to inspect the equipment, as the customer decided that they did not want an onsite visit for this case.Therefore, a cause for the overheating issue could not be determined.

• Brand Name: OR1 NEO IP, ENH2
• 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: 14733266
• MDR Text Key: 294405419
• Report Number: 9610617-2022-00097
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WUIS2548
• Device Catalogue Number: WUIS2548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• 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
• Patient Sex: Male