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

Model Number	TH104
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case on (b)(6) 2025 (case type was not provided), the image turned brown.They were able to complete the procedure using a back-up unit, without any patient impact.
Additional Manufacturer Narrative
The device was returned to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per evaluation conducted by the manufacturing site: complaint verified - manipulating the cable would cause image quality issues.A functional test found that moving the cable near the proximal end strain relief (ccu side of cable) would cause the blue color to drop out of the image resulting in a yellowish/brown picture.Once a test fixture cable was installed on the customer's camera the intermittent image issue could no longer be induced.When the original cable was re-installed, the issue returned, confirming the cable is intermittent.Additional inspection found the cable had a tacky feel, which suggests improper sterilization.The intermittent cable will require a replacement to resolve the customer's reported issue.This event is filed under internal 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 ; 4242188247
• MDR Report Key: 21521380
• Report Number: 2027009-2025-00317
• Device Sequence Number: 8378403
• Product Code: FET
• UDI-Device Identifier: 04048551333969
• UDI-Public: 04048551333969
• 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,Followup
• Report Date (Section B): 04/22/2025

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: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/23/2025
• 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