MAUDE Adverse Event Report: KARL STORZ SE & CO. KG AUTOCON III 400 HIGH-END, 100-127V; AUTOCON POWER GENERATOR

Model Number	UH400U
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a trans urethral resection of bladder tumor procedure on (b)(6) 2023, the wire sparked and popped.No patient harm was reported.Surgeon was able to complete the procedure by switching out the bipolar high frequency cable.
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).This complaint involves a total of 2 items: the uh400u autocon unit (complaint id (b)(4)), and uh801 bipolar high frequency cord (complaint id (b)(4)).
Additional Manufacturer Narrative
Per evaluation report by the manufacturer: product inspection: during the evaluation of the device, the errors listed above could not be reproduced according to the log file history.All entries in the log file are time-delayed because the time on the device was set incorrectly.The time of the potential incident (may 12, 2023) according to the customer's information can therefore not be assigned to the errors entered in the log file because the days are not correct.The rfid detection for the uh801 user cable does not work due to the defective front module.The fault may have been triggered by the defective uh801 user cable, which the customer claims to have transmitted.As a result, it is possible that the voltage was inductively fed back due to the sparking on the cable and consequently damaged the electronics of the front module.The supplied cable was cut by the customer and could therefore not be tested (see photo in the attachment).No entries in the log file concerning temperature problems with the appliance could be read out during operation.The foot switch connection sockets are slightly twisted due to mechanical influences on the rear panel (rear panel bent).This did not affect the footswitch function.Conclusion and root cause determination: the fault was almost certainly caused by the customer's uh801 user cable.According to the customer, the device worked again after replacing the user cable and the operation could then be completed without complications.The operating hours and cycles of the device are not recorded and therefore cannot be determined.This event is filed under internal complaint id (b)(4).

• Brand Name: AUTOCON III 400 HIGH-END, 100-127V
• Common Device Name: AUTOCON POWER GENERATOR
• 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: 17087042
• Report Number: 9610617-2023-00123
• Device Sequence Number: 6088600
• Product Code: GEI
• UDI-Device Identifier: 04048551378809
• UDI-Public: 4048551378809
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: 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: 05/12/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 02/07/2024
• 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 Age: 88 YR
• Patient Sex: Male