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
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.
Additional Manufacturer Narrative
The affected telescopes have been repaired by a third party, with the ks serial numbers removed - hence traceability is affected.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Complaint relates to an optic of the article 28300ba with severe image impairments and extreme dirt particles in the rod lens system.During inspection of the returned article the following was found: - third-party labelling 376m / not a karl storz serial number.- workpiece marking off-center.- mechanical damage to the distal end / chemical attack and leakage at the distal soldered seam.- dirt particles in the system due to leaks.- connection between shaft and body repaired by third party.The optics show severe chemical damage to the distal soldered seam and a broken rod lens.During the examination, a repair by a non-authorised karl storz repair centre was detected.The repair was carried out improperly and does not meet the karl storz quality standard.The optics were opened, which can be clearly seen.The serial number on the sheath was not applied by karl storz and does not correspond to the ks serial number sequence.Therefore, a product history for the item cannot be retrieved.The improper repair led to further damage (leakage of rod lens system).A production error can be ruled out due to the existing third-party repair damage.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Cross reference mdr: 9610617-2024-00376.

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo
• MDR Report Key: 20149990
• Report Number: 9610617-2024-00307
• Device Sequence Number: 12861191
• Product Code: HRX
• UDI-Device Identifier: 04048551111628
• UDI-Public: 04048551111628
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K943052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 10/01/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/16/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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