MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 8575GN

Model Number	8575GN
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the adjustment wheel on the 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.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
Correction to d4.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the returned items were examined.The customer complaint "not able to rotate to full angulation" can be confirmed the investigation revealed chip formation at the thread of the laryngoscope holder.Further tests revealed that the gear wheel rubs against the worm, resulting in pitting.The detailed analysis confirmed that malfunction was caused due to a manufacturing defect.The corresponding reprocessing instruction 8575ka_en_v1.1_ri_ce is requesting a visual inspection in chapter 8 as follows: check products for the following points: visible contamination; damage and corrosion; completeness; dryness.Subject any products displaying visible soiling to another complete cleaning and disinfection process.Discard damaged and corroded medical devices.Discard incomplete medical devices or replace missing parts.Dry the product by hand if necessary.Furthermore in chapter 10.1 functional check the following is listed: "if the product does not fulfill one of the points listed below or if damage can be identified, see chapter "maintenance, repair, and disposal" in the instructions for use.The following tests must be carried out to detect functional limitations: check the surface of the product for mechanical integrity and changes.Check the labeling for legibility.Check the product for mechanical integrity.Check the correct positioning of the assembled components and, if necessary, also.Check the cleaning connector.Check the mobility of all mobile components, if necessary once the components have been assembled in the case of products that can be dismantled.Check whether the end positions of the application part are reached." the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: 8575GN
• Common Device Name: 8575GN
• 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: 22937350
• Report Number: 9610617-2025-01522
• Device Sequence Number: 9755238
• Product Code: CCW
• UDI-Device Identifier: 04048551251805
• UDI-Public: 04048551251805
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2026

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: ZM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 12/17/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/05/2025; 01/13/2026
• 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: 8575KD, SUPPORT ROD, 34 CM, LOT/SN: (B)(6)
• Patient Sex: Unknown