MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HYSTEROSCOPE SHEATH, 5 MM

Model Number	R26153EA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.In the event the device returns and relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference complaint id: (b)(4).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 physician was trying to get the product through the cervix and the scope broke.The hysteroscope sheath and hopkins telescope 30°, 2.9 mm, 30 cm were attached (both instruments were being used during the procedure).It was reported during the hytersocopy procedure was prolonged for 30 minutes on (b)(6) 2024, the surgeon was not able to complete the procedure, the patient was referred to gyn cross reference mdr: 9610617-2025-00026.

• Brand Name: HYSTEROSCOPE SHEATH, 5 MM
• Common Device Name: HYSTEROSCOPE SHEATH, 5 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21270385
• Report Number: 2020550-2025-00025
• Device Sequence Number: 3943433
• Product Code: HET
• UDI-Device Identifier: 04048551094167
• UDI-Public: 04048551094167
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 01/29/2025
• Report Date (Section F): 01/14/2025

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: R26153EA
• Device Catalogue Number: R26153EA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• 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: Unknown
• Date Report Sent to FDA: 01/14/2025