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.
Additional Manufacturer Narrative
Complaint relates to an optic of the article 28300ba.We have received two optics (complaint no.(b)(4) that were sent to us by the customer due to severe image impairment.During inspection of the returned article 376m (b)(4).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.During inspection of the returned article 1782m (b)(4).The following was found: third-party labelling 1782m / 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 / moisture in the system due to leaks.The telescopes show significant foreign particles and moisture in the rod lens system.In addition, there is severe chemical damage to the distal soldered seam and a broken rod lens in one telescope (376m of (b)(4).).During the examination, an unauthorized repair by an unauthorized repair centre was detected in both telescopes we received.The repair was carried out improperly and does not meet the karl storz quality standard.Both telescopes were opened, which can be clearly seen.The serial numbers on the shafts were not applied by karl storz and do not match the ks serial number sequence.Therefore, no product history can be retrieved for the items listed.The improper repair resulted in consequential damage to both telescopes (leakage of the rod lens system).A production defect can be ruled out due to the existing damage from the third-party repair.The event is filed under internal karl storz complaint id: (b)(4).

• 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: 20446240
• Report Number: 9610617-2024-00376
• Device Sequence Number: 8165862
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/21/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown