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

Model Number	8575KA
Medical Device Problem Code	Mechanical Problem (1384)
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
No defect description was given by the customer.Technical inspection revealed chip formation at the thread of the laryngoscope holder.According to the event description there is no information that the event caused a harm or serious injury to patient, user or third.Since the risk analysis is based to patient, user or third party harms no risk-id is applicable to the reported event.Non-serious events are monitored through the trending process (q1.5.0001.Wi002).
Additional Manufacturer Narrative
Device evaluation: the examination of the returned device revealed chip formation at the thread, which confirmed the customer complaint.Further tests showed that the gear wheel rubs against the worm, resulting in pitting.The detailed analysis confirmed that the complaint was due to a technical defect of the worm.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: LARYNGOSCOPE HOLDER, GÖTTINGEN MODEL
• Common Device Name: LARYNGOSCOPE HOLDER, GÖTTINGEN MODEL
• 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: 23490690
• Report Number: 9610617-2025-02019
• Device Sequence Number: 4758831
• Product Code: CCW
• UDI-Device Identifier: 04048551210901
• UDI-Public: 04048551210901
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/21/2026

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: 8575KA
• Device Catalogue Number: 8575KA
• Device Lot Number: TL09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 04/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8575KB - LOT NUMBER WM06
• Patient Sex: Unknown