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

Model Number	26053SC
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Serious Injury
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.

• 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
• MDR Report Key: 22080597
• Report Number: 2020550-2025-00903
• Device Sequence Number: 15628988
• Product Code: HIH
• UDI-Device Identifier: 04048551410462
• UDI-Public: 04048551410462
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025
• Report Date (Section F): 05/23/2025

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: 26053SC
• Device Catalogue Number: 26053SC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2025
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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