MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DRILLCUT-X II-35 SHAVER HANDPIECE

Model Number	40712035
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that that prior to use, there was an error on the storz system when the tower was turned on.There was no patient involvement.No negative impact in state of health reported.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that when using the drillcut-x ii-35 motor may come to a standstill when used in shaver mode at speeds above 8,000 rpm.No negative impact in state of health reported.

• Brand Name: DRILLCUT-X II-35 SHAVER HANDPIECE
• Common Device Name: DRILLCUT-X II-35 SHAVER HANDPIECE
• 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: 23091984
• Report Number: 9610617-2025-01617
• Device Sequence Number: 21260375
• Product Code: ERL
• UDI-Device Identifier: 04048551409954
• UDI-Public: 04048551409954
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200318
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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: 40712035
• Device Catalogue Number: 40712035
• 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: 09/02/2025
• Initial Report FDA Received Date: 09/18/2025
• 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