MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUPPORT ROD, 34 CM

Model Number	8575KD
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there is a defect adjustment wheel on a laryngoscope holder.The wheel was stuck and not able to rotate the full angulation during procedure.Some tiny metal fragments were found on the gear after procedure.Acording to the customer no fragments fell in patient.The surgery was prolonged for 30 minutes.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
Additional information added in section d10 concomitant medical products.Device evaluation: (b)(4): upon examination of the rejected item 8575kd (batch wm02), it was found that the distal end had slight corrosion spots, which did not impair functionality.However, the nature of the damage indicates improper reprocessing, most likely caused by the customer.No connection could be established with the defect pattern of item 8575ka.This device shows no defects described in the complaint and is functioning as intended.(b)(4): the laryngoscope holder model göttingen (article no.8575gn, lot zm01) 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.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SUPPORT ROD, 34 CM
• Common Device Name: SUPPORT ROD, 34 CM
• 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
• MDR Report Key: 22905310
• Report Number: 9610617-2025-01492
• Device Sequence Number: 15666364
• Product Code: CCW
• UDI-Device Identifier: 04048551210932
• UDI-Public: 04048551210932
• 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
• Report Date (Section B): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8575KD
• Device Catalogue Number: 8575KD
• Device Lot Number: ZM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 02/20/2026
• 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: 8575KD. LOT/SN: LOT WM02.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown