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

Model Number	27040D
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that both the resectoscope and the cable overheated during the procedure, giving off a burnt smell.As the hospital did not have a replacement device available, they borrowed one from another hospital.Consequently, the operation was paused for 45 minutes.The procedure was successfully completed using the replacement device.No negative impact in state of health reported.Since the procedure was prolonged for 45 minutes, the case is deemed as reportable.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: during the manufacturer's technical inspection, the error description provided by the customer, "overheating resectoscope element & cable", could be confirmed.The cause of the defect is that liquid probably penetrated the cable at the transition point into the instrument plug.At this point, the liquid heated up significantly and exploded.The cause is wear and tear of the device.According to ifu, this could have been detected during a thorough inspection prior to use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• 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: 22895667
• Report Number: 9610617-2025-01471
• Device Sequence Number: 15677726
• Product Code: HIH
• UDI-Device Identifier: 04048551075470
• UDI-Public: 04048551075470
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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: 27040D
• Device Catalogue Number: 27040D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 02/05/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/24/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 279 CORD,HI FREQUENCY. CURVED.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown