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

Model Number	UH400U
Medical Device Problem Code	Energy Spectrum Incorrect (1210)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that during two turp cases the surgeon was unable to stop arterial bleeding, and the fulguration was extremely poor.The surgery time of both cases was prolonged.The patient treated during the first case needed to be reoperated, as he was still bleeding, and needed to stay in the hospital a few hours longer.Both patients went home the same day.This report represents the first of the two cases.
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 (b)(4).
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: - no.- no relevant (error) entries in the log file of the autocon.Defects found: ---chassis slightly dented in the area of the foot switch sockets.Conclusion and root cause determination: ---no error could be detected.The most probable cause is a defect in the periphery used.

• 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: 15942356
• Report Number: 9610617-2022-00328
• Device Sequence Number: 17694678
• 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?: Yes
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 03/16/2023
• 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: Required Intervention; Other; Hospitalization
• Patient Sex: Male