MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ASM,HEAD,IMAGE 1 S, 4U

Model Number	TH120
Medical Device Problem Codes	Break (1069); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during the procedure the picture of the camera is gone.After a short period the picture is back.No harm to patient, user or third reported.No negative consequences reported.
Additional Manufacturer Narrative
Result of investigation: the most probable root cause is that the mainboard of the tc201 is defective.As this is used for communication with all other products via the hive bus.The event is filed under internal karl storz complaint id: (b)(4).
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
Result of investigation: the most likely cause is that the camera head cable was responsible for the image failure.The camera head cable was mechanically damaged (cut and hole in the cable) and may have caused this failure.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,HEAD,IMAGE 1 S, 4U
• Common Device Name: HEAD,IMAGE 1
• 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: 20763152
• Report Number: 9610617-2024-00459
• Device Sequence Number: 13134985
• Product Code: FET
• UDI-Device Identifier: 04048551370506
• UDI-Public: 04048551370506
• Combination Product (Y/N): N
• Initial Reporter Country: MK
• PMA/510(K) Number: K131953
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TH120
• Device Catalogue Number: TH120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/04/2024; 01/15/2025; 04/04/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/27/2024; 01/28/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown