MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 2.4 MM, 10 CM; RIGID OPTICAL ARTHROSCOPE, REUSABLE

Model Number	28300BA
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information on third party repair: (b)(6) 2024.Device was repaired by third party and serial numbers were removed.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).
Event or Problem Description
It was reported that the scope was cloudy when used for ankle arthroscopy.Surgeon was unable to fulfill procedure plan due to poor vision.Cloudiness not visible to the eye.There was no other scope available for completion of procedure.Cross reference mdr: 9610617-2024-00307.

• Brand Name: HOPKINS TELESCOPE 30°, 2.4 MM, 10 CM
• Common Device Name: RIGID OPTICAL ARTHROSCOPE, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 20446692
• Report Number: 2020550-2024-00376
• Device Sequence Number: 8406215
• Product Code: HRX
• UDI-Device Identifier: 04048551111628
• UDI-Public: 04048551111628
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2024
• Report Date (Section F): 10/14/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 28300BA
• Device Catalogue Number: 28300BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2024
• 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: Other
• Patient Sex: Unknown