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	09/25/2023
Type of Reportable Event	Malfunction
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 (b)(4).
Event or Problem Description
It was reported that during a local balloon sinus dilation with turbs reduction on (b)(6) 2023, the motor function on the hand-piece stopped working.They had to move the patient to another room that carried an entellus debrider, where they completed the procedure with no patient injury.However, this issue caused the dr.To be behind schedule for about 30 minutes due to moving the patient to the other room.
Additional Manufacturer Narrative
Per evaluation result by the manufacturer: product inspection: fault diagnosis: motor defective.Motor blocked.Insulation test faulty.E20/19 (motor defective).Contamination in the appliance.Moisture has entered.Conclusion and root cause determination: the product has become very worn within a very short time.This may be due to incorrect cleaning (wrong agent or too long exposure time) or insufficient cleaning.The ifu describes how to check and ensure that the device is working properly before each use.It is most probable that the product has been damaged by incorrect cleaning.Correction / corrective action: no corrective actions necessary as there is no critical and/or systematic deviation found during investigation the current issue did not trigger the capa as per q3.3.0001 corrective and preventive action.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: 17916548
• Report Number: 9610617-2023-00283
• Device Sequence Number: 14176438
• 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
• Report Date (Section B): 01/29/2024

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: 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: 09/26/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 01/29/2024
• 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
• Patient Sex: Unknown