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

Model Number	TH120
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a vaaft procedure, the image on the monitor was lost for a brief second, twice in short succession.The surgeon said it was while using diathermy.[[?]] picture flickered when diathermy machine was being used then went off while using diathermy.Furthermore, it was confirmed that the procedure was completed successfully and there were no adverse consequences for the patient, user or third party.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected devices has been requested for investigation by the manufacturer.Devices will not be returned for investigation.The event is filed under internal karl storz 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: 21952233
• Report Number: 9610617-2025-00752
• Device Sequence Number: 9056202
• Product Code: FET
• UDI-Device Identifier: 04048551370506
• UDI-Public: 04048551370506
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/30/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TC003,DISPLAYPORT CABLE, 3M.
• Patient Sex: Unknown