MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UH400 AUTOCON® III 400; ELECTROSURGICAL UNIT

Model Number	UH400U
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and will be forwarded to the manufacturing site in germany for evaluation.This event is filed under internal complaint id (b)(4).
Event or Problem Description
Customer reported that three times during one case and two times during another the generator just stopped working.The touch screen was frozen and was not responsive and the foot pedal did not activate the generator.System was shut down and restarted; it worked and then froze again.The procedures were completed using a backup generator.There was no negative patient impact.This report represents the second of the two cases.
Additional Manufacturer Narrative
Per manufacturer evaluation findings: based on our initial investigation: by reviewing the similar complaint there is no indication for an increase/ trend of the reported issue.Customer complaint detected: yes; during test operation, the device "froze" without warning and operation was no longer possible.After switching off and on again, the device worked again.No relevant fault entries are recorded in the device's fault memory.Defects found: front unit defective ("freezes" sporadically, no operation of the device possible anymore).Conclusion and root cause determination: front panel module defective.Electronics defect.

• Brand Name: UH400 AUTOCON® III 400
• Common Device Name: ELECTROSURGICAL UNIT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15946954
• Report Number: 9610617-2022-00330
• Device Sequence Number: 17747151
• Product Code: GEI
• UDI-Device Identifier: 04048551378809
• UDI-Public: 04048551378809
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171717
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: UH400U
• Device Catalogue Number: UH400U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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: Male