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

Model Number	TH111
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
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.
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).
Additional Manufacturer Narrative
During investigation of the returned device the issue reported by the customer could be confirmed.It was found that when the cable sheath near the strain relief on the camera head is moved, the live image occasionally fails or artefacts are displayed.The video connection cable assembled at the camera head has some mechanical defects which are related to wear and tear.It is concluded that this is caused by the daily work with the camera head.The corresponding instructions for use of the device state to check the product for functionality and damage before and after every use and to have a replacement product ready for each application.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21952188
• Report Number: 9610617-2025-00754
• Device Sequence Number: 9122311
• Product Code: FET
• UDI-Device Identifier: 04048551358931
• UDI-Public: 04048551358931
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown