MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA. INC HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM

Model Number	R26120BA
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.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).
Event or Problem Description
It was reported that the scope had error message and blurry image that delayed the case for 45 minutes.No negative impact in state of health reported.

• Brand Name: HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA. INC; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 22321989
• Report Number: 2020550-2025-01092
• Device Sequence Number: 13008826
• Product Code: FAJ
• UDI-Device Identifier: 04048551093832
• UDI-Public: 04048551093832
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/24/2025
• Report Date (Section F): 06/10/2025

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: Other
• Device Model Number: R26120BA
• Device Catalogue Number: R26120BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• 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: Other
• Patient Age: 35 YR
• Patient Sex: Female