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

Model Number	26040XA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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).

• 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
• MDR Report Key: 19563105
• Report Number: 2020550-2024-00173
• Device Sequence Number: 7549653
• Product Code: HIH
• UDI-Device Identifier: 04048551092057
• UDI-Public: 4048551092057
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2024
• Report Date (Section F): 06/18/2024

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female