MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Nephroscope for MIP L

Model Number	27840KA
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "improper vision while using pcnl scope.The duration of the prolongation was approximately 1 hour.".
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: Nephroscope for MIP L
• Common Device Name: Nephroscope for MIP L
• Manufacturer (Section D): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 50350248
• Report Number: 50350248
• Device Sequence Number: 6063744
• Product Code: FGA
• UDI-Device Identifier: 04048551366660
• UDI-Public: 04048551366660
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2026
• Report Date (Section F): 08/20/2026

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: 27840KA
• Device Catalogue Number: 27840KA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• 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