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

Model Number	R28164LLA
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).Cross reference interal complaint id (b)(4).
Event or Problem Description
It has been reported that metal shavings may have detached from the scope.Metal flakes/ shavings were visible on the endoscope's surgical image.These were floating around in the ventricular space.It was not clear whether these came from the endoscope itself, the instruments used, or another source.Concomitant device filed under internal 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, deu 78532 ,; GM 78532,
• MDR Report Key: 24345312
• Report Number: 2020550-2026-00302
• Device Sequence Number: 9912587
• Product Code: GWG
• UDI-Device Identifier: 04048551279663
• UDI-Public: 04048551279663
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 02/16/2026
• Report Date (Section F): 02/16/2026

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: R28164LLA
• Device Catalogue Number: R28164LLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/22/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2026
• 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: 28161SB BIOPSY FORCEPS, 1.3 MM, 30 CM.; 28161SB BIOPSY FORCEPS, 1.3 MM, 30 CM.; 28161SG GRASPING FORCEPS, SEMIRIGID, 1.3 MM.; R27071TJ FOREIGN BODY FORCEPS, 28 CM.; R28161SC SCISSORS, SEMIRIGID, 1.3 MM, 30 CM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown