MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR.

Model Number	27294AA
Medical Device Problem Codes	Material Fragmentation (1261); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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 pcnl sudden loss of vision occurred and all lens of the telescope fall out." further received information indicates that the procedure was prolonged by more than 60 minutes and could not be completed successfully.The information also indicate that the procedure had to be postponed by 2 days and additional/prolonged hospitalization was required.

• Brand Name: HOPKINS TELESCOPE 6°, 18 FR.
• Common Device Name: HOPKINS TELESCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19105174
• Report Number: 2020550-2024-00106
• Device Sequence Number: 20753611
• Product Code: FAJ
• UDI-Device Identifier: 04048551233825
• UDI-Public: 4048551233825
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/15/2024
• Report Date (Section F): 04/15/2024

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: 27294AA
• Device Catalogue Number: 27294AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/12/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• 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: Hospitalization
• Patient Sex: Unknown