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
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.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.
Additional Manufacturer Narrative
Per evaluation findings by the manufacturer: fault diagnosis: ---pin damaged.---connector defective.Fault analysis: ---disassembly.---cover module including connection cable replaced.---seals replaced.---hollow shaft assembly including seal module replaced.---service / maintenance.---assembly and testing according to valid product specification.Cleaning.Conclusion and root cause determination: pin plug bent, therefore no function.User fault.Device should have been tested before use.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Correction: this incident was deemed as "adverse event", due to the fact, that the original procedure was unable to be completed.However, we previously submitted this medwatch only as "product problem".We therefore, will submit this correction now retrospectively.This event is filed under internal complaint id (b)(4).

• 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
• 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 ; 4242188247
• MDR Report Key: 17784687
• Report Number: 9610617-2023-00261
• Device Sequence Number: 5518951
• Product Code: ERL
• UDI-Device Identifier: 04048551253632
• UDI-Public: 4048551253632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 04/11/2024; 09/18/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 04/17/2024; 07/19/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown