MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH, 24 FR.

Model Number	27040BO
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported during a medical procedure on (b)(6) 2024, the doctor was removing bladder tumor and noticed there was a broken piece of the sheath inside of the patient.The broken piece was retrieved from the patient.No harm was caused to the patient.
Additional Manufacturer Narrative
Updated section d9 to yes and entered the device return date to the manufacturer.The device was returned to our us facility on december 13.2024.It 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
Per investigation by the manufacturing site: the article was manufactured in september 2007, so it can be assumed that it has been used and reprocessed a corresponding number of times.Exposure to cleaning agents, for example, can affect the material properties and change them.In addition, improper handling, e.G.During reprocessing (hitting the tip, etc.), can cause damage.The instructions for use recommend checking the shafts for damage and testing their function before each use.In addition, there is an external marking on the shaft that was not applied by kst.Further examination revealed that the ceramic insert had a different diameter than the shaft.During production, these are ground together in the assembled state.Based on these results, it can be assumed that the article has been repaired by a third party.The cause of the defect can therefore be traced back to the user.This event is filed under internal complaint id (b)(4).

• Brand Name: RESECTOSCOPE SHEATH, 24 FR.
• Common Device Name: RESECTOSCOPE SHEATH, 24 FR.
• 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: 20712258
• Report Number: 9610617-2024-00450
• Device Sequence Number: 9783279
• Product Code: HIH
• UDI-Device Identifier: 04048551392720
• UDI-Public: 04048551392720
• 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): 07/21/2025

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: 27040BO
• Device Catalogue Number: 27040BO
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 12/13/2024; 07/16/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/20/2024; 07/21/2025
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 84 KG