MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TWO-PEDAL FOOTSWITCH HF GENERATORS

Model Number	UF902
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2025
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.Cross reference internal complaint id (b)(4).This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that insufficient monopolar cautery.Patient involved.Patient was injured; customer had to get a blood transfusion.Physician was attempting to cauterize with the 5mm roller-ball monopolar electrode and insufficient cautery caused excessive bleeding.Coagulation was maxed at 120 watts.Patient had to have blood transfused.Cross reference mfr report # 1221826-2025-00638.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the device was sent to the manufacturer for investigation.During the manufacturer's technical inspection, the error description provided by the customer, " it was reported that insufficient monopolar cautery.Patient involved.Patient was injured, customer had to get a blood transfusion.Physician was attempting to cauterize with the 5mm roller-ball monopolar electrode and insufficient cautery caused excessive bleeding.Coagulation was maxed at 120 watts.Patient had to have blood transfused" could be confirmed.The root cause of the malfunction is a defective power board, which wore out after approx.7 years.The investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The complaint history did not reveal any pickup in similar complaints, no trend was identified.The ifu 96206584us version 3.2 contains the following note on page 30: 4.4 test for proper functioning: among others to perform the following functional test before putting the device into service: in case of problems in section 4.4.3 the following is described: 1.Immediately disconnect the patient from the hf device.2.Perform a technical inspection of the hf device.3.Observe the relevant national regulations.Observe the provisions of the in-housereporting system in this regard.4.Consult the technical support this event is filed under internal complaint id (b)(4).

• Brand Name: TWO-PEDAL FOOTSWITCH HF GENERATORS
• Common Device Name: TWO-PEDAL FOOTSWITCH HF GENERATORS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21873781
• Report Number: 9610617-2025-00639
• Device Sequence Number: 7653649
• Product Code: GEI
• UDI-Device Identifier: 04048551372203
• UDI-Public: 04048551372203
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/31/2025

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: UF902
• Device Catalogue Number: UF902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/31/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 101 KG