MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LITTLE LOTTA VENTRICULOSCOPE

Model Number	28164LLA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
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 during an endoscopic ventriculostomy in 2022, an incident occurred that led to bleeding with consequences for the patient.The patient became a nursing case.Detailed information provided by the reporter about the procedure: the patient's head was adequately fixed in the mayfield clamp.The guide sleeve was navigationally introduced into the lateral ventricle and then under visualisation and navigational guidance through the foramen monroi into the 3rd ventricle.During this process, the assistant held the endoscope at the level of the burr hole with his fingers and fixed the entry point at the burr hole.Due to contamination, the optic was pulled out and cleaned.When reinserting the optic, the surgeon held the endoscope with the afferent irrigation and the efferent drainage with his left hand and inserted the optic with his right hand.A wobbling motion occurred due to a catch when the optics were inserted into the guide sleeve.It was later visible in the mri that the endoscope slipped further inwards as a result and there was a contusion of the midbrain.

• Brand Name: LITTLE LOTTA VENTRICULOSCOPE
• Common Device Name: LITTLE LOTTA VENTRICULOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21637714
• Report Number: 2020550-2025-00449
• Device Sequence Number: 6828653
• Product Code: GWG
• UDI-Device Identifier: 04048551279663
• UDI-Public: 04048551279663
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/18/2025
• Report Date (Section F): 03/18/2025

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: 28164LLA
• Device Catalogue Number: 28164LLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• 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: Disability
• Patient Sex: Unknown