MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FIXED, FOR 26040SL

Model Number	26040XA
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a operative hysteroscopy on (b)(6) 2024, the beak of the inner sheath broke inside a female patient.No patient injury was reported, and they were able to complaint the procedure without any other issue.
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
Update information: customer confirmed that they will not return the device to us for evaluation.Therefore, the device will not 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 evaluation by the manufacturing site: according to the customer's description, the ceramic insert is broken off/broken on the distal side.The most likely cause of this is that the shaft has been damaged by improper handling (e.G.Being caught in the outer shaft, pre-damage caused by preparation, etc.).As the article is already over 14 years old, it has reached its "end of life".A more detailed examination cannot be carried out as the article was not returned.This event is filed under internal complaint id (b)(4).

• Brand Name: INNER SHEATH, FIXED, FOR 26040SL
• Common Device Name: INNER SHEATH, FIXED
• 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 ; 4242188247
• MDR Report Key: 19563018
• Report Number: 9610617-2024-00173
• Device Sequence Number: 15328767
• Product Code: HIH
• UDI-Device Identifier: 04048551092057
• UDI-Public: 4048551092057
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/14/2025

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: 26040XA
• Device Catalogue Number: 26040XA
• Device Lot Number: RY01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 02/27/2025
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 01/03/2025; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female