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

Model Number	WUIS2546
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a case, the nurse was shocked when touching the aida bella smartscreen.No other information was provided, other than there was no injury to the nurse nor the patient reported, nor any other impact to the procedure.
Additional Manufacturer Narrative
The device will not be forwarded to the manufacturing site for investigation.Rather, we will send our service tech to evaluate the device in the field.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).

• Brand Name: OR1 NEO IP, ENH
• Common Device Name: OR1 NEO IP, ENH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 19563694
• Report Number: 2020550-2024-00176
• Device Sequence Number: 11748250
• Product Code: OUG
• UDI-Device Identifier: 04048551415320
• UDI-Public: 4048551415320
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2024
• Report Date (Section F): 06/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WUIS2546
• Device Catalogue Number: WUIS2546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/22/2024
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown