MAUDE Adverse Event Report: KARL STORZ IMAGING CCU,MODULAR,IMAGE1 S X-LINK,US; CCU MODULAR

Model Number	TC301US
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
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 complaints id (b)(4).There were two different ccus (as the causal items) involved in the case.See below for the details: ccu#1 item number tc301us / serial number: (b)(6) / internal complaint id (b)(4) / mdr #(b)(4).Ccu#2 item number tc201us / serial number: (b)(6) / internal complaint id (b)(4) / mdr #(b)(4).
Event or Problem Description
It was reported that during an ureteroscopy case on (b)(6) 2023, the image was flickering back and forth between the menu and the main viewing image.There was no patient injury due to this, however they were unable to complete the case and had to reschedule to a different date.
Additional Manufacturer Narrative
The manufacturer was made aware that image stability issues exist when using a 91279 single-use flex xc1 scope with a tc301us that has software v4.4 installed.The customer only returned their tc201us and tc301us for evaluation.During testing, process engineering verified that the system would intermittently display an "incompatible head" message.However, no image dropouts or image flickering was encountered during testing.The customer's tc301us and tc201us were upgraded to software 4.5 and the "incompatible head" message was no longer detected.Upgrading the system to software v4.5 will correct the v4.4 tc301 and flex xc1 compatibility issues.This event is filed under internal complaints id (b)(4).There were two different ccus (as the causal items) involved in the case.See below for the details: ccu#1 item number tc301us / serial number: (b)(6) / internal complaint id (b)(4)/ mdr #24-06.Ccu#2 item number tc201us / serial number: (b)(6) / internal complaint id (b)(4)/ mdr #24-07.
Additional Manufacturer Narrative
Correction: this incident was deemed as "adverse event" due to the fact that the original procedure was unable to be completed.However, we previously submitted this medwatch only as "produt problem".We therefore will submit this correction now retrospectively.This event is filed under internal complaints id (b)(4).

• Brand Name: CCU,MODULAR,IMAGE1 S X-LINK,US
• Common Device Name: CCU MODULAR
• 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 ; GM 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 18499721
• Report Number: 2027009-2024-00006
• Device Sequence Number: 12750279
• Product Code: FET
• UDI-Device Identifier: 04048551356562
• UDI-Public: 4048551356562
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

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: TC301US
• Device Catalogue Number: TC301US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023; Not provided
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/13/2024; 07/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ITEM 091279-01/INTERNAL COMPLAINT (B)(4).; ITEM 091279-01/INTERNAL COMPLAINT (B)(4).; ITEM 091279-01/INTERNAL COMPLAINT (B)(4).; ITEM 091279-01/INTERNAL COMPLAINT (B)(4).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown