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

Model Number	26040GP1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device will not return for investigation due to the customer did not save the broken electrodes.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).Cross reference internal complaint id (b)(4).
Event or Problem Description
It was reported during a medical procedure on (b)(6) 2025 two (2) electrodes broke.According to the doctor, a piece was retained in the patient and they did not save the broken electrodes.Cross reference medwatch number 2020550-2025-01400.

• Brand Name: CUTTING LOOP, BIPOLAR, 26 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR, 26 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• MDR Report Key: 22777209
• Report Number: 2020550-2025-01399
• Device Sequence Number: 9288963
• Product Code: HIN
• UDI-Device Identifier: 04048551392720
• UDI-Public: 04048551392720
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/11/2025
• Report Date (Section F): 08/11/2025

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: 26040GP1
• Device Catalogue Number: 26040GP1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2025
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• 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: Other
• Patient Sex: Unknown