MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH, 15 FR.

Model Number	26053SC
Medical Device Problem Codes	Material Deformation (2976); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, the 15fr resector handle exploded inside the patient, burning the optics and damaging the 26053cb sheath.Both the working element and the cable have been found to be in perfect condition.Fortunately, the patient has not been harmed.According to the information received, there was a visible spark while inside the patient, the physical structure of the apparatus (the insulation of the sheath) broke, and debris were found inside the patient.These debris were removed from the patient before surgery was completed.Also, additional intervention required to remove the broken part during the surgery.Therefore, this case is an injury and 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
As the responsible product for the event (011050-10) has not been returned, a final determination of the root cause is not possible.A review of similar complaints on this product code results in the most likely root cause of mechanical overloading the cutting loop wire, resulting in a break and final touching the neutral electrode, creating a short cut which leads to the described "explosion".Hint in the ifu of the electrode, to prevent such events, is already present.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: RESECTOSCOPE SHEATH, 15 FR.
• Common Device Name: RESECTOSCOPE SHEATH, 15 FR.
• 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: 22080460
• Report Number: 9610617-2025-00903
• Device Sequence Number: 18318560
• Product Code: HIH
• UDI-Device Identifier: 04048551410462
• UDI-Public: 04048551410462
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2025

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: 26053SC
• Device Catalogue Number: 26053SC
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 09/23/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/18/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (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: MATERIAL NUMBER: 011050-01; MATERIAL NUMBER: 26053CB; MATERIAL NUMBER: 26053EB (WORKING ELEMENT); MATERIAL NUMBER: 26120AA; MATERIAL NUMBER: UF902 (; MATERIAL NUMBER: UH400; MATERIAL NUMBER: UH801
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown