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

Model Number	8575KA
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.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).
Event or Problem Description
According to the information received, metal shards inside.A protein test was performed and it showed negative, confirming it's coming from the gear wheel inside.According to the available information, there was no patient involved.And the issue occurred not during a procedure.
Additional Manufacturer Narrative
Device evaluation: the laryngoscope holder model göttingen (article no.8575ka, lot pl24) 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.This event is filed under internal complaint id (b)(4).

• Brand Name: LARYNGOSCOPE HOLDER, GÖTTINGEN MODEL
• 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: 22922264
• Report Number: 9610617-2025-01483
• Device Sequence Number: 9235805
• Product Code: EQN
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: 8575KA
• Device Catalogue Number: 8575KA
• Device Lot Number: PL24
• Date Returned to Manufacturer: 08/20/2025
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 09/04/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/29/2025; 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