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

Model Number	28164LLA
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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.
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).
Additional Manufacturer Narrative
Device evaluation: as the device in question was not returned, an investigation on the product itself could not be performed.However, the available information has been reviewed.The investigation was completed on july 3,2025.The product mentioned in the report was not returned for further physical examination and cause analysis.Hence, it was not possible to verify the cause of the described hooking/wobbling.However, within the provided information by the initial reporter it was stated that there was no doubt about the correct function of the product.It can therefore be assumed that the product functioned as intended and that the problem described was more likely caused by factors related to its use.If the product is returned in the future, the case will be reopened and the results of the root cause analysis will be included in a new report.As of today, and with the current knowledge, there is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can most likely be traced back to a usage-related failure.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21637708
• Report Number: 9610617-2025-00449
• Device Sequence Number: 12469559
• Product Code: GWG
• UDI-Device Identifier: 04048551279663
• UDI-Public: 04048551279663
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K982837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown