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

Model Number	8575KD
Medical Device Problem Codes	Material Fragmentation (1261); 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	Serious Injury
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).

• 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
• MDR Report Key: 22906100
• Report Number: 2020550-2025-01492
• Device Sequence Number: 18375775
• Product Code: CCW
• UDI-Device Identifier: 04048551210932
• UDI-Public: 04048551210932
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025
• Report Date (Section F): 08/27/2025

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
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown