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

Model Number	TH102
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Shielding Failure (1568)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screens all flickered and went black during use which caused a delay of under 15mins.The procedure could be completed successfully.No harm to patient, user or third occurred.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: because none of the products were returned and no further information concerning the issue is provided by the customer, the conclusion is done by experience of the investigator only.The most probable root cause therefore seems to be a defective camera head cable of the th102.This leads the signal transmitted to the control unit (tc300)to fail and consequently to a disturbance in the displaying unit (monitor, not part of this investigation).The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,HEAD,IMAGE1 S,H3-Z FI,CE
• Common Device Name: IMAGE1
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20126898
• Report Number: 2027009-2024-00301
• Device Sequence Number: 3226576
• Product Code: OWN
• UDI-Device Identifier: 04048551333150
• UDI-Public: 04048551333150
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: TH102
• Device Catalogue Number: TH102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (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