MAUDE Adverse Event Report: KARL STORZ IMAGING IMAGE1 S, H3-2 CE; IMAGE1, HEAD

Model Number	TH100
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.This report is due to similar complaint assessment.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the image cut out during case no patient injury.Procedure was completed using a back-up camera.The surgery was delayed approximently 5 to 6 minutes.Additional patient information is not available.
Additional Manufacturer Narrative
Complaint verified - no loss of image was detected over multiple days of testing, but internal moisture was observed: internal moisture will reduce image quality.Multiple overnight burn-in sessions were performed without complete loss of image being detected.With an image displayed, the cable was heavily manipulated, and the housing was exposed to significant mechanical shock, yet no image loss was induced.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: IMAGE1 S, H3-2 CE
• Common Device Name: IMAGE1, HEAD
• 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 90245-5017 ; 4242188738
• MDR Report Key: 16158999
• Report Number: 2027009-2023-00014
• Device Sequence Number: 17882267
• Product Code: FET
• UDI-Device Identifier: 04048551333136
• UDI-Public: 4048551333136
• Combination Product (Y/N): N
• 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): 02/09/2023

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: TH100
• Device Catalogue Number: TH100
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/09/2023
• 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