MAUDE Adverse Event Report: KARL STORZ IMAGING ASM,CAMERA HEAD,HX,1080P

Model Number	TH110
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that when connecting camera to camera box, no image, not recognizing.Tested with another camera that worked fine.Used one time for a prior procedure with no issues.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as when connecting the camera to the camera box, no image and not recognizing.The customer's complaint was verified.The camera would not produce an image.A functional test confirmed the complaint.A visual inspection was unable to detect any issues of abuse or physical damage.Troubleshooting found a short between the cable proximal end pins 5 (up1_n) & 7 (up1_p).This short prevents proper communication between the camera and ccu, and it explains the customer's reason for return.The cable was removed from the headboard and the short was still present - this isolates the short to the 051529-00 cable.Troubleshooting indicates an internal issue with the encapsulated end of the cable, which can't be repaired or evaluated further at ksna goleta.The customer's issue was caused by a faulty cable, which needs to be replaced.The cause of the issue was determined as cable short between proximal end pins 5 & 7.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,CAMERA HEAD,HX,1080P
• Common Device Name: ASM,CAMERA HEAD,HX,1080P
• 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: 23660609
• Report Number: 2027009-2025-02185
• Device Sequence Number: 18422872
• Product Code: FET
• UDI-Device Identifier: 04048551358924
• UDI-Public: 04048551358924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160044
• 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: TH110
• Device Catalogue Number: TH110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 11/26/2025
• 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