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

Model Number	27050XA
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received, a part of the sheath detached and migrated into the patient's bladder during the procedure.
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).
Additional Manufacturer Narrative
Device evaluation: as the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.The investigation was completed on 30-may-2025.The device product history records (dhr) have been checked for the available lot number and found to be according to the specification, valid at the time of production.According to the information provided, the article in question was manufactured in 2018 (lot number).This means that the instrument has already been in use for seven years.It cannot be ruled out that the article has reached the end of its life cycle.As an instrument ages, it can suffer from material fatigue or signs of wear.In this case, it is possible that the adhesive bond between the shaft and ceramic tip has loosened over time.This could have caused the ceramic tip to separate from the shaft.Another possible cause is the formation of microcracks in the material, which develop over extended use and can eventually lead to breakage of the ceramic part.Based on the available information, the failure description and similar complaints, it can be concluded that this is an application error that may have occurred due to failure to follow the recommended instructions for use and preparation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.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).
Additional Manufacturer Narrative
Result of investigation: as the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.The investigation was completed on (b)(6) 2025.The device product history records (dhr) have been checked for the available lot number and found to be according to the specification, valid at the time of production.According to the information provided, the article in question was manufactured in 2018 (lot number).This means that the instrument has already been in use for seven years.It cannot be ruled out that the article has reached the end of its life cycle.As an instrument ages, it can suffer from material fatigue or signs of wear.In this case, it is possible that the adhesive bond between the shaft and ceramic tip has loosened over time.This could have caused the ceramic tip to separate from the shaft.Another possible cause is the formation of microcracks in the material, which develop over extended use and can eventually lead to breakage of the ceramic part.Based on the available information, the failure description and similar complaints, it can be concluded that this is an application error that may have occurred due to failure to follow the recommended instructions for use and preparation.Update: investigation with product was completed on december 12, 2025.The fault description provided by the customer, "part of the sheathing has come loose," was confirmed.The investigation revealed that the damage is on the lamella on the rear part of the shaft not at the ceramic beak on the tip.The breakage of the lamella at the rear of the product were caused by mechanical overload.The event is filed under internal karl storz complaint id:(b)(4).

• Brand Name: INNER SHEATH FOR 27050 SL
• Common Device Name: INNER SHEATH FOR 27050 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: 21748824
• Report Number: 9610617-2025-00539
• Device Sequence Number: 13120964
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 04048551078136
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2026

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: 27050XA
• Device Catalogue Number: 27050XA
• Device Lot Number: SR04
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 06/25/2025; 12/12/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/12/2025; 07/11/2025; 01/09/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown