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 not verified.The issue was isolated to the customer's other th120 camera (reference complaint id (b)(4).Two th120 cameras were received and had the same reason for return.The 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.Unable to duplicate the customer's issue with this service order.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: 2027009-2025-01623.

• 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: 23087134
• Report Number: 2027009-2025-01622
• Device Sequence Number: 10508849
• 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