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

Model Number	27050XA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a turp biopsy procedure on (b)(6) 2024, there was a breakage of the ceramic.No negative impact in state of health reported, the doctor was able to remove the broken piece floating around and there was a surgal delay of approximately 25 minutes while attempting to remove the broken pieces.However, it was reported that it's hard to tell if the broken piece may have cut the patient on the way out.
Additional Manufacturer Narrative
It is unknow if the device will be returned to the manufacturing site for investigation.In the event the device returns and 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
Correction has been made to sections d1, d2a, d2b and d4 updated the material number from r27050xb to 27050xa.The device in question was returned to the manufacturer on february 7, 2025.This information is reflected in section d9.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
Per investigation by the manufacturing site: the fracture of the ceramic beak could have been caused by pulling out the inner shaft at an angle from the outer shaft.This misalignment puts pressure on the ceramic, which is thereby pressed against the outer shaft, which can lead to a fracture.Ceramic is a brittle material with a high degree of hardness, but it is prone to microcracks.Such cracks can expand under stress or after repeated use and ultimately lead to a fracture.The instructions for use (ifu) indicate that the ceramic beak must be checked for damage before each use.In addition, the manufacturing code indicated that the article was produced in 2018, which means that it is already 7 years old.It can therefore be assumed that the life cycle of the article has been reached or exceeded.During this period, microcracks could have formed due to use and ageing, which ultimately led to the breakage.Ceramics are particularly sensitive to sudden mechanical loads or punctual pressure.For this reason, it is essential to carefully check the material before each use, as also described in the instructions for use and reprocessing.In view of the improper handling observed and the advanced age of the article, it is assumed that user error led to the damage observed.This event is filed under internal 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, 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: 21092139
• Report Number: 9610617-2024-00550
• Device Sequence Number: 15619397
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 04048551078136
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/03/2025

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: 27050XA
• Device Catalogue Number: 27050XA
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: Not provided; 05/08/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/12/2025; 06/03/2025
• 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 Age: 60 YR
• Patient Sex: Unknown