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

Model Number	8575GN
Medical Device Problem Codes	Circuit Failure (1089); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
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 adjustment wheel on 8575gn lewy laryngoscope holder was stuck and not able to rotate to the full angulation when the chest support was placed during procedure.Some tiny metal fragments were found on the gear but did not fell into patient.No negative impact in state of health reported.".
Additional Manufacturer Narrative
Device evaluation: chip formation at the thread could be seen, which confirmed the failure description of the complaint by the customer.Further tests showed that the gear wheel rubs against the worm, resulting in pitting.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: LEWY LARYNGOSCOPE HOLDER
• Common Device Name: LEWY LARYNGOSCOPE HOLDER
• 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: 23066696
• Report Number: 9610617-2025-01621
• Device Sequence Number: 21294440
• Product Code: CCW
• UDI-Device Identifier: 04048551251805
• UDI-Public: 4048551251805
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 05/21/2026

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: 8575GN
• Device Catalogue Number: 8575GN
• Device Lot Number: NP02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 05/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 8575KB, LOT/SN: LOT: (B)(6).
• Patient Sex: Unknown