MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ASM,CAMERA HEAD,HX,PENDULUM,1080P

Model Number	TH111
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the image is distorted on screen which makes the picture difficult to see.It was furthermore stated that this was notice during a patient procedure, but there were no adverse consequences and the procedure was successfully completed.No negative impact in state of health reported.Additional information was received on 25-apr-2025.Regarding the reported error it was stated "no image output and screen displayed with multiple lines flickering when the camera was used on the patient".Furthermore, it was confirmed again that the procedure was completed successfully and the patient got discharged home safe, but it was also indicated that the procedure was prolonged between 30 and 60 minutes.

• Brand Name: ASM,CAMERA HEAD,HX,PENDULUM,1080P
• Common Device Name: ASM,CAMERA HEAD,HX,PENDULUM,1080P
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21952186
• Report Number: 2020550-2025-00754
• Device Sequence Number: 13042096
• Product Code: FET
• UDI-Device Identifier: 04048551358931
• UDI-Public: 04048551358931
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/02/2025
• Report Date (Section F): 05/02/2025

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: TH111
• Device Catalogue Number: TH111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2025
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• 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