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.
Additional Manufacturer Narrative
Damage can be identified, see chapter 'maintenance, repair, servicing and disposal' in the instructions for use.The following tests must be carried out to detect functional limitations: check the surface of the product for mechanical integrity and changes.Check the labeling for legibility.Check the product for mechanical integrity.Check the correct positioning of the assembled components and, if necessary, also check the cleaning connector.Check the mobility of all mobile components, if necessary, once the components have been assembled in the case of products that can be dismantled.Check whether the end positions of the application part are reached." the complaint history did not reveal any pickup in similar complaints; no trend was identified: (b)(4).
Additional Manufacturer Narrative
Correction in section h6 to void code 4315 from the last report.Also, correction to the evaluation summary from the last report in section h11.Please see below: during a holep procedure, the ceramic tip of the tur inner sheath broke.Technical examination revealed a significantly weakened bond between the ceramic and the shaft.The findings indicate a gradual degradation of the adhesive bond due to the effects of reprocessing, corrosive processes, and mechanical stress during use and handling.Assuming proper and professional application and reprocessing, karl storz has validated electrical safety for a total of 400 cycles.The 27040xa / inner shaft, for 27040 sd/sl was manufactured in may 2024.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.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: 23089321
• Report Number: 9610617-2025-01630
• Device Sequence Number: 15876392
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 04048551076521
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 03/11/2026; Not provided
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 03/13/2026; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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