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

Model Number	TH111
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 will be forwarded 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).
Event or Problem Description
It was reported that the device did not work when the customer tried to use it for the first time.They double checked it again, and still no image.No negative impact in state of health reported.
Additional Manufacturer Narrative
This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The device was returned to our us facility (as documented in section d9), and will later be forwarded 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 evalulation findings by the manufacturing site: no image is being produced by the camera.A functional test confirmed the failure.A visual inspection observed broken traces on the card edge connector pins.These broken pins caused continuity issues which prevented the camera head from communicating with the ccu.The cable is over 9 years old and needs to be replaced to address the customer's issue.The customer's processing protocols should be reviewed to ensure that they are not accelerating the life of the cable.The root cause was determined as broken continuity on card edge.This event is filed under internal complaint id (b)(4).

• Brand Name: ASM,CAMERA HEAD,HX,PENDULUM,1080P
• Common Device Name: ASM,CAMERA HEAD,HX,PENDULUM,1080P
• 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: 22004084
• Report Number: 2027009-2025-00747
• Device Sequence Number: 9115083
• Product Code: FET
• UDI-Device Identifier: 04048551358931
• UDI-Public: 04048551358931
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 06/19/2025

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: TH111
• Device Catalogue Number: TH111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 05/16/2025; 06/16/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 05/13/2025; 05/19/2025; 06/19/2025
• 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