MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR

Model Number	27040EB
Medical Device Problem Codes	Loss of or Failure to Bond (1068); 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, 9610617-2025-00051, 9610617-2025-00052, 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).
Event or Problem Description
Additional information: the patient had a bipolar bladder resection on (b)(6) 2025.The surgeon indicated that there was no medical intervention required.The surgery was delayed for 20-30 minutes, but they were able to complete the procedure with a new set of scopes and new generator.
Additional Manufacturer Narrative
Additional information added to section b5.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: this error is caused by the defective shaft 27040xa.The ceramic of the inner shaft is broken.It is assumed that the loop during application, for example, by levering, pushing to the side, bent.This could cause the loop to catch on the defective part of the ceramic.Since the missing parts of the ceramic insert have reduced the distance to the metal surface, the current could jump here and flow over the instrument and optics to the neutral electrode, which caused the electrode to break down.Since the optics are located in the immediate vicinity of the electrode, they also suffered severe damage as a result.The entire combination was also tested for the error description "parts were in a case were the tip of cutting loop exploded.The surgeon went into the anatomy, just to observe, was plugged into generator.Surgeon had not activated the foot pedal, and it charred the bladder bad." the problem could not be reproduced.The current only flowed when the foot switch was pressed.The above conducted 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 devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: WORKING ELEMENT, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21222413
• Report Number: 9610617-2025-00053
• Device Sequence Number: 19664811
• Product Code: FDC
• UDI-Device Identifier: 04048551075623
• UDI-Public: 04048551075623
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/20/2025

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: 27040EB
• Device Catalogue Number: 27040EB
• Device Lot Number: PM09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 01/10/2025; 05/07/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 01/24/2025; 05/20/2025
• 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: Other
• Patient Sex: Unknown