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

Model Number	8575KA
Medical Device Problem Codes	Mechanical Jam (2983); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that metal shavings fell out during surgery".The shavings were coming out of the metal wheel of the rod and were outside of the surgical field.All of the chips (shavings) could be recovered in all three cases.The procedure was completed successfully.No surgical delay or prolongation and no medical/ surgical/ diagnostical intervention required.No negative impact in state of health reported.
Additional Manufacturer Narrative
The laryngoscope holder model göttingen article no.8575ka was not returned for investigation.Investigation on an earlier, comparable complaint revealed the following: 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 detailed analysis confirmed that the complaint was due to a an internal corrective- and preventive action was initiated for improvement.The instruction for use 96056371df v2.0-10/2017 contains the following warnings on page 3: warning: risk of injury to the patient/user: damaged or incomplete instruments/accessories may cause malfunctions.Always check instruments/ accessories before and after use to ensure that nothing is missing/damaged.Replace incomplete/ damaged instruments/accessories and do not continue to use them.Before every use, check that all the instruments required for the operation are functioning correctly.Warning: check the instrument and accessories used in combination before every application for unintentional rough surfaces, sharp corners, burred edges, and projecting parts, which can endanger personal safety.Damaged, bent, or incomplete instruments or accessories must not be used further under any circumstances.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 90245
• MDR Report Key: 22722171
• Report Number: 9610617-2025-01363
• Device Sequence Number: 21125607
• Product Code: CCW
• UDI-Device Identifier: 04048551210901
• UDI-Public: 04048551210901
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/30/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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