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 uf/importer report # 2020550-2025-00638.

• 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,
• MDR Report Key: 21873797
• Report Number: 2020550-2025-00639
• Device Sequence Number: 7803244
• Product Code: GEI
• UDI-Device Identifier: 04048551372203
• UDI-Public: 04048551372203
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2025
• Report Date (Section F): 04/21/2025

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 101 KG