MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SC

Model Number	27050CA
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
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
It was reported that a resectoscope has being used with green light laser via compatible laser working insert 27050vl.The surgeon fired laser while inside the sheath resulting in the inner sheath breaking off - the ceramic beak broke off inside.The visible broken parts were retrieved.The remaining broken parts were expelled via irrigation.The surgeon and team were satisfied as there were no remaining parts in patient.The surgery was prolongued for less than 15 minutes.No negative impact in state of health reported.Cross referebce mdr: 9610617-2025-00006.
Additional Manufacturer Narrative
Result of investigation: the examination of the 27050ca article confirmed that the ceramic tip had a fracture.In addition, soot residue was found on the ceramic.It is likely that the defect was caused by a combination of microcracks in the ceramic and thermal damage.Microcracks can result from mechanical stress and material fatigue and affect the stability of the ceramic.The soot marks found on the ceramic tip are also an indication that the laser was used in the shaft.The defect probably occurred because the laser was activated too early or too far into the shaft, instead of being activated outside the shaft first.As a result, the laser hit the ceramic tip directly, causing it to break due to thermal overload.Ceramic is a brittle material that is sensitive to thermal stress and point-like mechanical impacts.Heat can cause existing micro-cracks to spread quickly and weaken the ceramic structure, which can lead to breakage.In the corresponding ifu: 97000126 v3.0_03/2019 on page 3 is a warning not to overload the instrument by exerting too much force.Too much force may cause the medical device to break.In addition a second warning is listed on the same page that, among others, the ceramic tip must be checked for cracks or other damage each time they are used.And that damaged sheaths (chips or cracks) must never be used since damaged sheaths could lead to patient injury.Article: 27050vl inner sheath for 27050 sc was not returned for examination thus a product inspection cannot be conducted.The reported error is on the article 27050ca and not on article 27050vl.Internal karl storz reference number: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SC
• Common Device Name: INNER SHEATH FOR 27050 SC
• 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: 21103844
• Report Number: 9610617-2025-00005
• Device Sequence Number: 13041010
• Product Code: FJL
• UDI-Device Identifier: 04048551077412
• UDI-Public: 04048551077412
• 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
• Report Date (Section B): 01/20/2025

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: 27050CA
• Device Catalogue Number: 27050CA
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/21/2025
• 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
• Patient Sex: Unknown