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

Model Number	8403XD
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
According to the information received, there was "hardware: when turning the monitor left/right, it occasionally switches off, loose connection, the data cannot be read on the pc because it is not recognized by explorer.".No patient involvement reported.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the evaluation of the error description provided was confirmed, and further defects (image quality not acceptable, socket to application part defective) were detected.The cause of the image error is a defective socket, which negatively affects the image.This fault and all other defects found are due to signs of wear and tear caused by use.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: 23381730
• Report Number: 9610617-2025-01868
• Device Sequence Number: 4939962
• Product Code: CCW
• UDI-Device Identifier: 04048551396032
• UDI-Public: 04048551396032
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• 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): 04/02/2026

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?: No
• 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: 10/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 04/02/2026
• 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