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

Model Number	UH400U
Medical Device Problem Codes	Blocked Connection (2888); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2024
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 turbt case on july-02-2024, the device did not work and the surgeon could not cauterize the tissue.They also smell smoke out of the device, however there they did not see any smoke nor the device got hot.They had to bring in a back-up tower to complete the procedure.No patient injury was reported.However, it caused a delay to the case of about 30 minutes.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: there are no entries in the log file that indicate a malfunction of the device.The bipolar connection socket 3, which is contaminated by the liquid ingress, could cause errors during operation if the solution that has entered is still liquid.When it has dried out, the behavior is not as pronounced or is not relevant.But whether this liquid ingress is responsible for the customer's description is questionable.There are no signs of burnt components, nor is there any visual evidence of overheating inside the device.There are only signs of wear on the monopolar sockets 1 and 2, which do not affect the function of the device.No accessories were sent in with the device that could be examined.It is possible that the customer's connecting cables used during the incident may have been damaged.This event is filed under internal complaint id (b)(4).

• Brand Name: AUTOCON III 400 HIGH-END, 100-127V
• Common Device Name: AUTOCON III 400 HIGH-END, 100-127V
• 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: 19914283
• Report Number: 9610617-2024-00240
• Device Sequence Number: 12786046
• Product Code: GEI
• UDI-Device Identifier: 04048551378809
• UDI-Public: 04048551378809
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: UH400U
• Device Catalogue Number: UH400U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 195 KG