MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC® POCKET MONITOR

Model Number	8403XD
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that image freezes when the monitor is rotated.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the device was sent to the manufacturer for inspection.The manufacturer's technical inspection confirmed the fault description provided by the customer ("image freezes when the monitor is rotated").The following defects were identified in total: customer complaint noted, socket for application part defective, device not recognised by pc, image quality not satisfactory, stripes/interference in the image, device surface visually worn.The device passed the quality test at the time of delivery.Based on the defects identified during the technical inspection, it is concluded that the fault described is due to normal wear and tear.The cause of the image failure is the damaged socket on the application part, which means that the connection is no longer correct and the device fails.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: C-MAC® POCKET MONITOR
• Common Device Name: C-MAC® POCKET MONITOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22876890
• Report Number: 9610617-2025-01423
• Device Sequence Number: 14875269
• Product Code: CCW
• UDI-Device Identifier: 04048551396032
• UDI-Public: 04048551396032
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: 8403XD
• Device Catalogue Number: 8403XD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/08/2025
• 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