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

Model Number	27040XB
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during transurethral waterjet ablation of prostate procedure the beak broke off.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.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).
Additional Manufacturer Narrative
We received mdr number (b)(4), which the customer filed from their end.Updated sections e4 and h11 to reflect this new information.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the analysis of item 27040xb, lot uo02 clearly shows that the breakage of the ceramic beak is not attributable to a manufacturing or assembly defect.Instead, the available findings paint a consistent picture of failure caused by use or user error.The combination of irregular fracture edges, multiple independent fracture lines, and the ceramic and adhesive residues remaining in the shaft indicates that microcracks were already present in the ceramic prior to the final fracture.These microcracks typically result from mechanical pre-damage such as impact loads, drops, or tilting during handling or reprocessing.Additionally, the partially washed-out adhesive indicates a progressive weakening of the adhesive bond, as facilitated by repeated thermal and chemical reprocessing cycles.Taking all technical findings into account, the damage is therefore highly likely the result of mechanical stress during use or reprocessing resulting progressive microcracking in the ceramic, and a partial reduction in the adhesive bond over the course of use.These factors ultimately led to a brittle final fracture of the ceramic tip during the procedure.Based on the characteristics of the damage and the findings, a manufacturing defect can be ruled out with a high degree of probability.The conducted investigations did not reaveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings e.G.Instructions for use.Resectoscope sheaths.218dcd_en_v2.1_07-2024_ifu_fda.This event is filed under internal complaint id (b)(4).

• Brand Name: INNER SHEATH, FOR 27040 SM
• Common Device Name: INNER SHEATH, FOR 27040 SM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 22817544
• Report Number: 9610617-2025-01427
• Device Sequence Number: 8703696
• Product Code: FJL
• UDI-Device Identifier: 04048551076569
• UDI-Public: 04048551076569
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27040XB
• Device Catalogue Number: 27040XB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 05/18/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/16/2025; 05/21/2026
• 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
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 90 KG