MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTOSCOPE SHEATH, 22 FR.; Cystoscope And Accessories, Flexible/Rigid

Model Number	27026B
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
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 the tip of the instrument 27026c broken during surgery and was subsequently removed from the patient's bladder.The duration of the surgical prolongation was between 15 and 60 minutes.No negative impact in state of health reported.
Additional Manufacturer Narrative
Correction made in sections d1, d2, d4.In addition, device was returned to the manufacturing site as documented in section d9.This event is filed under internal complaint id (b)(4).

• Brand Name: CYSTOSCOPE SHEATH, 22 FR.
• Common Device Name: Cystoscope And Accessories, Flexible/Rigid
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, ; GM
• 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: 23512006
• Report Number: 9610617-2025-02035
• Device Sequence Number: 9733282
• Product Code: FAJ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K243653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/01/2026

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: 27026B
• Device Catalogue Number: 27026B
• Device Lot Number: ED
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 09/04/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/04/2025; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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