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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & Co. KG C-MAC Connecting Cable

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KARL STORZ SE & Co. KG C-MAC Connecting Cable Back to Search Results
Model Number 8403X
Medical Device Problem Codes Mechanical Problem (1384); Output Problem (3005)
Health Effect - Clinical Codes Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/09/2026
Type of Reportable Event Serious Injury
Event or Problem Description
The following was reported: during a procedure yesterday, the device switched off.There was an intermittent electrical/contact failure while the video system was being used in an emergency situation.The procedure was completed successfully but medical, surgical, or diagnostic intervention was required.No adverse consequences reported.Cross reference mdr: 9610617-2026-01714; 9610617-2026-01715; 9610617-2026-01860; 9610617-2026-01861.
 
Additional Manufacturer Narrative
The device in question was returned to manufacturer for evaluation as reflected in section d9.The investigation is not yet complete; investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).Cross reference internal complaint id: (b)(4).
 
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Brand Name
C-MAC Connecting Cable
Common Device Name
C-MAC Connecting Cable
Manufacturer (Section D)
KARL STORZ SE & Co. KG
dr.-karl-storz-strasse 34
tuttlingen 78532
GM  78532
MDR Report Key50225677
Report Number50225677
Device Sequence Number13327350
Product Code CCW
UDI-Device Identifier04048551389225
UDI-Public04048551389225
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/12/2026
Report Date (Section F) 08/12/2026
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? Yes
Operator of Device Health Professional
Device Model Number8403X
Device Catalogue Number8403X
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/28/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/03/2026
Event Location Hospital
Date Report to Manufacturer08/12/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/12/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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