MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH, 22 FR.

Model Number	26055SC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that a "fluid leakage was observed during bipolar resection of uterine polyps.The leakage was so intense that the procedure had to be interrupted.Polyps were not removed.The leak occurred from the sheath and the working element.The procedure has not been completed".No death or (unanticipated) serious deterioration in state of health reported.

• Brand Name: RESECTOSCOPE SHEATH, 22 FR.
• Common Device Name: RESECTOSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 20600071
• Report Number: 2020550-2024-00433
• Device Sequence Number: 6567495
• Product Code: HIH
• UDI-Device Identifier: 04048551306727
• UDI-Public: 04048551306727
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 11/05/2024
• Report Date (Section F): 10/31/2024

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: 26055SC
• Device Catalogue Number: 26055SC
• Device Lot Number: VM01 4048551306727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• 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: Unknown