MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CONNECTING CABLE

Model Number	8403XDP
Medical Device Problem Codes	Break (1069); Optical Problem (3001)
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.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 that if the user "connect the cable with a screen and a 8404ax, the image cut himself".No negative impact in state of health reported.
Additional Manufacturer Narrative
Information is corrected in section d4.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the conducted investigations did not reveal a root cause related to the labeling or history of the product.The labeling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints, no trend was identified.During the examination of 8403xdp a mechanical damage has been identified.The damage can lead to the issue described by the customer.As not all products of the claimed setup were returned and no additional information has been received, no further investigations can be made.Due to the above stated results, the root cause can be identified as damage to the cable by the user.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CONNECTING CABLE
• Common Device Name: CONNECTING CABLE
• 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: 21266607
• Report Number: 9610617-2025-00069
• Device Sequence Number: 8451351
• Product Code: CCW
• UDI-Device Identifier: 04048551396049
• UDI-Public: 04048551396049
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2025

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: 8403XDP
• Device Catalogue Number: 8403XDP
• Device Lot Number: SM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/06/2025; 02/18/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/06/2025; 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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