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

Model Number	TH100
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as cloudy image.The karl storz goleta service department evaluated and documented the following issues with th100 serial number (b)(6) (old serial number (b)(6)).The customer's complaint was verified.The following defects were found: optics are jumpy/binding.Cable leak due to cut/hole.Grasping mechanism does not function properly.Housing serial number/ udi label is damaged/ unreadable.Zoom knob has corroded/ rusted magnets.Focus knob has corroded/ rusted magnets.The following karl storz goleta service findings are consistent with a cloudy image: jumpy/binding optics, a cut in the cable, malfunctioning grasping mechanism, and corroded magnets on the zoom/focus knobs.Based on the camera's previous repair history it's recommended that the customer reviews their handling/processing methods to ensure they are following approved karl storz protocols.A conclusive root cause could not be determined by karl storz goleta process engineering since the camera wasn't physically evaluated by ks goleta pe.However, the defects documented during the incoming evaluation by karl storz goleta service are consistent with the customer's cloudy image complaint.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: "cloudy image" no negative impact in state of health reported.

• Brand Name: ASM,HEAD,IMAGE1 S,H3-Z, CE
• Common Device Name: ASM,HEAD,IMAGE1 S,H3-Z, 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: 23746951
• Report Number: 2027009-2025-02189
• Device Sequence Number: 9365472
• Product Code: FET
• UDI-Device Identifier: 04048551333136
• UDI-Public: 04048551333136
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 12/08/2025

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: TH100
• Device Catalogue Number: TH100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 12/08/2025
• 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
• Patient Sex: Unknown