MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LARYNGOSCOPE HOLDER, W. ADJUSTMENT WHEEL; Laryngoscope, Nasopharyngoscope

Model Number	8574KU
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983)
Health Effect - Clinical Codes	Immunodeficiency (2156); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the locking in the wheel and during the wash, particles are coming out of the instrument.Shaving particles falling out during the case.A backup device was used, and the procedure was completed successfully with a delay of 5-10 minutes.No customer harm.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The laryngoscope holder model göttingen (article no.8574ku, lot zm01) was examined following a customer complaint.The investigation 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.Machining by grinding showed only a slight improvement.Comparison with an older gear wheel (2002) indicated that the problem lies with the worm itself.The detailed analysis confirmed that the complaint was due to a technical problem with the worm and was not a handling error.In addition, we would like to call your attention to a warning in the corresponding instructions for use.This event is filed under internal complaint id: (b)(4).

• Brand Name: LARYNGOSCOPE HOLDER, W. ADJUSTMENT WHEEL
• Common Device Name: Laryngoscope, Nasopharyngoscope
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 22980873
• Report Number: 9610617-2025-01558
• Device Sequence Number: 18372288
• Product Code: EQN
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K252624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 8574KU
• Device Catalogue Number: 8574KU
• Device Lot Number: ZM01
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 03/16/2026; 09/04/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 03/17/2026; 09/29/2026
• 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