MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DISTENDING FAN RETRACTOR

Model Number	26173FP
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "when the surgeon opens the retractor and places it near the liver, if it is moved, the branches of the retractor shift and damage the organ." due to a possible damage of the liver, this case is deemed reportable.No further details regarding the nature of the injury (severity) are available at this time.
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).

• Brand Name: DISTENDING FAN RETRACTOR
• Common Device Name: DISTENDING FAN RETRACTOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 24491913
• Report Number: 2020550-2026-00409
• Device Sequence Number: 10676753
• Product Code: HET
• UDI-Device Identifier: 04048551098004
• UDI-Public: 04048551098004
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/02/2026
• Report Date (Section F): 03/02/2026

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: 26173FP
• Device Catalogue Number: 26173FP
• Device Lot Number: WL01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• 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