MAUDE Adverse Event Report: KARL STORZ IMAGING CCU MODULAR 4U LINK; CCU MODULAR FOR IMAGE1 4K CAMERA HEADS

Model Number	TC304US
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned by the facility, however; no evaluation findings are available at this time.Once full product evaluation has been completed if needed a supplemental report will be filed.
Event or Problem Description
Per conversation with karl storz representative and the facility, after a septorhinoplasty procedure a "small reddish blemish" was noted post op with no awareness to a patient follow up.
Additional Manufacturer Narrative
Per manufacturer's investigation: complaint not verified - no overheating issues were detected during testing with the equipment that was returned.The following equipment was returned for the complaint investigation: tc201us, serial number: (b)(6).Tc304us, serial number: (b)(6).Th120, serial number: (b)(6).Th120, serial number: (b)(6).The above-mentioned equipment was tested together over two days without issue.Each camera was burned-in overnight, but the system operating temperatures never came close to a point that could cause a burn.Furthermore, the equipment returned does not contact the patient, so these four items are unlikely to be the source of any potential burns.Ultimately, a condition that could cause a burn was not duplicated over 2 days of testing.

• Brand Name: CCU MODULAR 4U LINK
• Common Device Name: CCU MODULAR FOR IMAGE1 4K CAMERA HEADS
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• MDR Report Key: 11448893
• Report Number: 2027009-2021-00024
• Device Sequence Number: 19837129
• Product Code: FET
• UDI-Device Identifier: 04048551418123
• UDI-Public: 4048551418123
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: TC304US
• Device Catalogue Number: TC304US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other