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

Model Number	TC301US
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
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 during a cystoscopy procedure on (b)(6) 2024, the device gave an error and not responding.They were able to complete the procedure using a single-use scope without any patient impact.However, this issue caused a delay to the procedure for about 30 minutes.
Additional Manufacturer Narrative
The device was returned to our us facility on nov-18-2024, 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 evaluation by the manufacturing site: the customer's complaint was verified.The tc301us ccu failed to link to tc201us/tc200us test fixtures.A functional test confirmed the customer's complaint.Troubleshooting resolved the issue by replacing the power supply (ksi part#: 053070-05 rev.Ba).With a test fixture power supply installed the ccu was burned-in overnight without issue.Karl storz does not have access to the power supply schematic, so a specific part could not be identified.Ultimately, a power supply replacement is required to address the customer's issue.Power supply info: (b)(6) part#: bpc000129 rev.E1: serial number: (b)(6).This event is filed under internal complaint 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: 20667352
• Report Number: 2027009-2024-00448
• Device Sequence Number: 7371470
• Product Code: FET
• UDI-Device Identifier: 04048551356562
• UDI-Public: 04048551356562
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 12/04/2024

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: TC301US
• Device Catalogue Number: TC301US
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 11/25/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 11/22/2024; 12/04/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 82 KG