MAUDE Adverse Event Report: KARL STORZ IMAGING 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per evaluation findings by the manufacturing site: the customer's complaint was verified.The camera could not sustain a quality image.Two th120 cameras (this one and complain id: (b)(4) were received and had the same reason for return.The other scope under complaint id: (b)(4) was tested for 6 days without issue.This included several overnight burn-in sessions.Also, significant mechanical shock was applied to the housing and the cable was heavily manipulated, yet no image failures could be induced.However, the scope for this complaint id: (b)(4) immediately failed to produce a stable image; light pressure on the cable would cause the image to routinely drop out.A visual inspection found that the camera associated with the other returned scope had a 3rd party cable installed.When a known working test fixture cable was installed, no further issues were encountered.The 3rd party cable installed on this camera will need to be replaced to address the customer's issue.The cause of the issue was determined as faulty 3rd party cable installed on camera.This event is filed under internal complaint id: (b)(4).Cross reference complaint id: (b)(4).
Event or Problem Description
It was reported that "when the camera head is connected to the camera box, the image flickers, and the surgeon cannot see the patient's anatomy".No negative impact in state of health reported.The patient was moved anesthetized, to another or for the procedure to be completed.They pulled a new camera head for the case to move on in a different or.There was a delay of at least one hour.Cross reference mdr: 2027009-2025-01622.

• Brand Name: ASM,HEAD,IMAGE 1 S, 4U
• Common Device Name: ASM,HEAD,IMAGE 1 S, 4U
• 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 ; 4242188247
• MDR Report Key: 23087257
• Report Number: 2027009-2025-01623
• Device Sequence Number: 9796347
• Product Code: FET
• UDI-Device Identifier: 04048551370506
• UDI-Public: 04048551370506
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male