MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR.

Model Number	27040GP1-S
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer will not return the device for evaluation.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference complaint id: (b)(4).This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported that during a medical procedure using uf400 and 27040fp1-s the patient was burned.The uf400 turn on it's own no petal was stepped on and it was possible it was on the wrong setting.Cross reference medwatch 9610617-2025-00803.
Additional Manufacturer Narrative
New information has been provided updated sections a2, a3a and a4.Correction has been made to section b5 correcting the narrative with the correct material numbers uh400u and 27040gp1-s.Cross reference complaint id: (b)(4).This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported that during a medical procedure using uh400u and 27040gp1-s, the patient was burned.The uh400u turn on its own no petal was stepped on and it was possible it was on the wrong setting.Cross reference medwatch 9610617-2025-00803.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: as the device in question was not returned, a technical inspection is not possible.No product history review possible to confirm that the sling was repackaged and sterilized in the us and assigned a new batch number.The lot number from kst is unknown.Based on the event description the uh400u is deemed the causative device and the investigation therefore focuses on the uh400u.Cross reference complaint id (b)(4).This event is filed under internal complaint id (b)(4).
Event or Problem Description
Cross reference medwatch 9610617-2025-00803.

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• 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: 21971369
• Report Number: 9610617-2025-00804
• Device Sequence Number: 8141849
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 04048551393482
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K221893
• 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,Followup
• Report Date (Section B): 07/09/2025

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: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: 37DD7685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: Not provided; 06/23/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/15/2025; 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 66 KG