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

Model Number	40712050
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This incident was coded as "adverse event" due to the fact that the original procedure was unable to be completed.However we failed to file the importer medwatch, and therefore will submit the importer medwatch now retrospectively.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that during a procudure on (b)(6) 2023, the motor function on the hand-piece stopped working.Device displayed e-19 error message (motor malfunction).They were unable to complete the procedure, and had to re-schedule.Customer confirmed that there was no patient injury due to this.

• Brand Name: DRILLCUT-X II SHAVER HANDPIECE
• Common Device Name: DRILLCUT-X II SHAVER HANDPIECE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 19785826
• Report Number: 2020550-2023-00261
• Device Sequence Number: 8654589
• Product Code: ERL
• UDI-Device Identifier: 04048551253632
• UDI-Public: 4048551253632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/19/2024
• Report Date (Section F): 09/18/2023

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: 40712050
• Device Catalogue Number: 40712050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2024
• 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