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

Model Number	UH400E
Medical Device Problem Codes	Unintended Power Up (1162); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the resectoscope machine was showing a footswitch error in which the machine was turned on/off multiple times.The surgeon then proceeded to use the machine and when removing their foot from the pedal the machine remained engaged.Resulting in a small burn on the uterine wall of a patient.".
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Section h7 in the last supplemental report was accidentally selected.This supplemental report is to clarify that there is no relabeling for this product.Additional information was provided in section h6 with an additional medical device problem code.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
During investigation no faults were found in the products (uh400e & uf902) that could lead to the device malfunction described by the customer.It is concluded that the most probable cause could be that the foot switch has been lightly touched by an external object, which could lead to the described activation.The foot switch shows signs of heavy external use, but no impact on its functionality was found.Internal karl storz reference number: (b)(4).

• Brand Name: AUTOCON III 400 HIGH-END, 100-127V
• Common Device Name: AUTOCON III 400 HIGH-END
• 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
• MDR Report Key: 18291401
• Report Number: 9610617-2023-00390
• Device Sequence Number: 6667602
• Product Code: GEI
• UDI-Device Identifier: 04048551378809
• UDI-Public: 4048551378809
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2024

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: UH400E
• Device Catalogue Number: UH400E
• Device Lot Number: 401038888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 03/15/2024; 03/15/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/08/2024; 03/18/2024; 03/20/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UF902 TWO-PEDAL FOOTSWITCH HF GENERATORS UP03972
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown