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

Model Number	TH120
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the camera presented a shaking image and sometime a black screen.The shaking is not permanent.It occured few times the sound of the units are very acute and is suggesting a fan problem.This situation occured during use and during a test in our technical department.The procedure was completed successfully with no surgical delay or prolongation of surgery.No negative impact in state of health reported.Cross reference: (b)(4).
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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
Device evaluation: during the manufacturer's technical inspection of the returned devices, the error description provided by the customer, "shaking image /black screen sometimes" could not be confirmed.Even though the 3 associated units, tc201, tc304 and th120 were tested in the system in continuous operation over several days, the described failure of the customer could not be detected/ determined.The most probable root cause therefore is the cabling on site which may have a loose or not correct connected connection.This event is filed under internal complaint id (b)(4).

• Brand Name: ASM,HEAD,IMAGE 1 S, 4U
• Common Device Name: ASM,HEAD,IMAGE 1 S, 4U
• 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: 22589313
• Report Number: 9610617-2025-01289
• Device Sequence Number: 18393569
• Product Code: FET
• UDI-Device Identifier: 04048551370506
• UDI-Public: 04048551370506
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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
• Report Date (Section B): 12/04/2025

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
• Date Returned to Manufacturer: 07/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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