MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL

Model Number	27040XA
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
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
During the urological surgery, the distal ceramic part of the sleeve became detached and fell into the bladder.Because of this, the procedure took longer than expected and unscheduled instruments had to be used.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the detachment of the distal ceramic component during surgery is most likely attributable to a combination of mechanical overstress, material deformation, and progressive degradation of the adhesive bond.These factors collectively led to a structural weakening of the connection between the stem and the ceramic tip, ultimately resulting in component failure.Preventive measures to avoid such incidents are clearly outlined in the instructions for use (ifu) and the reprocessing instructions.It is the user's responsibility to carefully follow and consistently apply these instructions.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH, FOR 27040 SD/SL
• Common Device Name: INNER SHEATH, FOR 27040 SD/SL
• 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: 22974198
• Report Number: 9610617-2025-01549
• Device Sequence Number: 8973084
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 04048551076521
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2025

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: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: SO03
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 11/03/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/09/2025; 11/06/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown