MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LARYNGOSCOPE HOLDER, GÖTTINGEN

Model Number	8575KA
Medical Device Problem Code	Mechanical Jam (2983)
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
It was reported that the device had been wearing out with some metal powder on it, and the defect was noted after reprocessing procedure and not involving medical procedure" there is no information that the event caused a harm or serious injury to patient, user or third.
Additional Manufacturer Narrative
Device evaluation: result of investigation: accordingly, we would like to give a summary of our results regarding the reported issue.The investigation of the returned product revealed chip formation at the thread, which confirmed the customer complaint.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: LARYNGOSCOPE HOLDER, GÖTTINGEN
• Common Device Name: LARYNGOSCOPE HOLDER, GÖTTINGEN
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo, ca ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA
• MDR Report Key: 22709115
• Report Number: 9610617-2025-01349
• Device Sequence Number: 9759611
• Product Code: CCW
• UDI-Device Identifier: 04048551210901
• UDI-Public: 04048551210901
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: 8575KA
• Device Catalogue Number: 8575KA
• Device Lot Number: UL06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/30/2025
• 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