MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUCTION AND COAG.CANNULA, L.30 CM

Model Number	37270DL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the surgeon was using the electrode probe to push down the fibroid.It was then the surgeon realized that the tip of the instrument was missing.It was agreed upon to shoot x-ray to determine whether the tip was left inside the patient or dropped out.After x-ray, it was found that tip was left inside the patient.The patient had to undergo removal of the tip.

• Brand Name: SUCTION AND COAG.CANNULA, L.30 CM
• Common Device Name: SUCTION AND COAG.CANNULA, L.30 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, ; GM
• MDR Report Key: 23534355
• Report Number: 2020550-2025-02056
• Device Sequence Number: 18413009
• Product Code: KNF
• UDI-Device Identifier: 04048551155530
• UDI-Public: 04048551155530
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 11/12/2025
• Report Date (Section F): 11/12/2025

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: 37270DL
• Device Catalogue Number: 37270DL
• Device Lot Number: TZ4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 30804 - HANDLE WITH TRUMPET VALVELOT GA
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown