MAUDE Adverse Event Report: KARL STORZ IMAGING ASM,HEAD,IMAGE1 S,H3-ZA, CE

Model Number	TH104
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the customer tried to turn on the unit that came from the repair and got a black screen".No negative impact in state of health reported.
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
Device evaluation: the complaint issue was described as turned on and got an image, then squiggly lines and then a black screen.The customer's complaint was verified.During the service process, it was determined that the customer's reason for return was caused by a defective cable.The customer cable was just previously replaced on (b)(6) 2025 for card edge contamination.It's highly recommended that the customer reviews their handling/sterilization methods to ensure they are following approved karl storz protocols.Also, the customer ccu receptacle should be evaluated for corresponding contamination that could also cause future image stability issues or accelerated wear on the newly replaced camera cable card edge.Replacing the cable should address the customer's reason for return.The cause of the issue was determined as defective cable.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,HEAD,IMAGE1 S,H3-ZA, CE
• Common Device Name: ASM,HEAD,IMAGE1 S,H3-ZA, CE
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta, ca 93117 ; GM 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta, ca 93117 ; GM 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23853578
• Report Number: 2027009-2025-02379
• Device Sequence Number: 15852809
• Product Code: FET
• UDI-Device Identifier: 04048551333969
• UDI-Public: 04048551333969
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: TH104
• Device Catalogue Number: TH104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/16/2026
• 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
• Patient Sex: Unknown