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

Model Number	27040XA
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	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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).
Event or Problem Description
It was reported that the ceramic tip of the inner sheath broke into 2 pieces just after starting to diathermy inside patient bladder.The surgeon was able to retrieve the broken ceramic tip after a long struggle.The surgery was extended between 30 and 60 mins.No negative impact in state of health reported.The surgery was completed but delayed for more than 30 mins.Therefore the event is deemed reportable.

• 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
• MDR Report Key: 23089277
• Report Number: 2020550-2025-01630
• Device Sequence Number: 10516471
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 04048551076521
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2025
• Report Date (Section F): 09/18/2025

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: SL07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/17/2025
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown