MAUDE Adverse Event Report: KARL STORZ IMAGING IMAGE1 S H3-Z HIGH DEF CAMERA HEAD; ENDOSCOPIC CAMERA

Model Number	TH100
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the first review, the camera connection cable is defective.The investigation is still pending.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4): during surgery, the image of the camera was intermittent.The customer switched to open surgery.
Additional Manufacturer Narrative
A field service technician was on site and investigated the device in question.After replacement of the external camera cable, the device passed all tests as per factory's specification.The defective cable was sent to the manufacturer for evaluation.According to the investigation results, the camera cable had loose contact on the bend protection head side.According to the instructions for use (material #96206511d, version 3.0 - 10/2017) it is recommended that a replacement system is kept available.
Additional Manufacturer Narrative
Section b1 of this reported was corrected to reflect an adverse event.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: IMAGE1 S H3-Z HIGH DEF CAMERA HEAD
• Common Device Name: ENDOSCOPIC CAMERA
• 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 avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12320991
• Report Number: 2027009-2021-00059
• Device Sequence Number: 19583718
• Product Code: FET
• UDI-Device Identifier: 04048551333136
• UDI-Public: 4048551333136
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2023

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: TH100
• Device Catalogue Number: TH100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 07/16/2021; 02/22/2023
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/02/2021; 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2014
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown