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

Model Number	TH104
Medical Device Problem Codes	No Display/Image (1183); 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 device has no image.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to 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: during the manufacturer's technical inspection, the error described by the customer as 'no image' was confirmed and assigned to a defective camera head cable.The th100 was found to have a cable that was visually in good condition.However, it did not work as expected.It is unclear whether the th104 worked for a while or failed on first use after the last repair.The cause of the failure was an electrical component fault.According to the ifu visual as well as functionality should always be checked before every use to avoid injuries and damages to the product.Furthermore, a spare device should be available in case the device fails during use.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
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22153264
• Report Number: 2027009-2025-00979
• Device Sequence Number: 7829388
• Product Code: FET
• UDI-Device Identifier: 04048551333969
• UDI-Public: 04048551333969
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: TH104
• Device Catalogue Number: TH104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 11/06/2025
• 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