MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 5 MM, 29 CM

Model Number	R26046BA
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).Cross reference complaint id: (b)(4).
Event or Problem Description
According to the information received, the lens on the scope does not show clear images; very blurry.It has been involved in a patient incident that resulted in harm: while dealing with the adhesions a small hole in the lung was created.Cross reference mdr: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 5 MM, 29 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 5 MM, 29 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 25660448
• Report Number: 2020550-2026-01466
• Device Sequence Number: 5701742
• Product Code: GCJ
• UDI-Device Identifier: 04048551092132
• UDI-Public: 04048551092132
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/29/2026
• Report Date (Section F): 06/29/2026

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: R26046BA
• Device Catalogue Number: R26046BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2026
• 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