MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Support Rod, 34 cm; Laryngoscope, Nasopharyngoscope

Model Number	8575KD
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was determined that both the product code and 510(k) number associated with this device were incorrect and have since been updated.This event is filed under internal complaint id (b)(4).

• Brand Name: Support Rod, 34 cm
• 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 ; +1(424)218-8247
• MDR Report Key: 50304019
• Report Number: 9610617-2026-01959
• Device Sequence Number: 16127729
• Product Code: EQN
• UDI-Device Identifier: 04048551210932
• UDI-Public: 04048551210932
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/23/2026

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: 8575KD
• Device Catalogue Number: 8575KD
• Device Lot Number: VM01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 09/04/2026; 09/04/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/22/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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