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

Model Number	27040XA
Medical Device Problem Codes	Sparking (2595); Noise, Audible (3273); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported during a turp procedure, at some point a piece of ceramic broke.A post op x-ray was obtained to determine if the piece had flushed out or stayed in patient.

• 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, deu 78532 ,; GM 78532,
• MDR Report Key: 22159076
• Report Number: 2020550-2025-00927
• Device Sequence Number: 20656121
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 04048551076521
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 06/06/2025
• Report Date (Section F): 06/03/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/08/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2025
• 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: Other
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 91 KG