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

Model Number	8403XD
Medical Device Problem Codes	No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993)
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 manufacturer.This information is reflected in section d9.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 "occasionally no image, photo/video resolution does not work." no negative impact in state of health reported.
Additional Manufacturer Narrative
The device concerned (8403xd, serial# (b)(6)) was sent to the manufacturer for inspection.During the technical inspection by the manufacturer the fault description received (occasionally no image, photo/video resolution does not work) could not be confirmed.The technical inspection did not reveal any faults with the monitor.The device only shows slight signs of wear on the surface, which cannot lead to the reported image failure.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
• MDR Report Key: 22487160
• Report Number: 9610617-2025-01214
• Device Sequence Number: 8554682
• 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): 03/17/2026

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?: 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: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 03/17/2026
• 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