MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.

Model Number	27040GP130-S
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cutting loop exploded during a case.According to the information received, the consequence of the explosion is that the bladder was charred.The surgeon was not concerned about any long-term harm to the patient.Cross reference mdr: 9610617-2025-00048, 9610617-2025-00049, 9610617-2025-00050, 9610617-2025-00052, 9610617-2025-00053, 9610617-2025-00054.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on january 21,2025.The evaluation is anticipated, but not yet begun.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference complaint id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21222418
• Report Number: 2020550-2025-00051
• Device Sequence Number: 14284454
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 04048551393864
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/23/2025
• Report Date (Section F): 01/23/2025

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: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Device Lot Number: 37IJ2837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2025
• 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