MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR.

Model Number	27294AA
Medical Device Problem Codes	Material Fragmentation (1261); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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 "during pcnl sudden loss of vision occurred and all lens of the telescope fall out." further received information indicates that the procedure was prolonged by more than 60 minutes and could not be completed successfully.The information also indicate that the procedure had to be postponed by 2 days and additional/prolonged hospitalization was required.
Additional Manufacturer Narrative
Result of investigation: according to the customer, the distal cover glass has come loose, and all the rod lenses have fallen out of the system tube, resulting in total loss of imaging.At the time of the failure, the optics had already been in use for 5 years.The optics were sent back by the customer.Unfortunately, the optics were routed incorrectly when the goods were received so that the optics were not forwarded to the responsible service unit as a complaint.Due to this, the optics were irretrievably lost and could not be physically investigated.Based on the customer's information, the damage can be attributed to a possible reprocessing error (media used, insertion time, reprocessing duration).Based on empirical values of identical optics and complaints from the customer's country (india), a reprocessing error is the most possible cause of failure.In the case of identical or similar optics from the country in question, a detached cover glass due to a chemically attacked or totally dissolved distal solder seam can very often be observed, which causes the loss/impairment of imaging.The reprocessing instructions of the product include important information about the correct cleaning, disinfection, inspection and functional check that must be carried out.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 6°, 18 FR.
• Common Device Name: HOPKINS TELESCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA
• MDR Report Key: 19105175
• Report Number: 9610617-2024-00106
• Device Sequence Number: 7682125
• Product Code: FAJ
• UDI-Device Identifier: 04048551233825
• UDI-Public: 4048551233825
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K943176
• 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): 07/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27294AA
• Device Catalogue Number: 27294AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization
• Patient Sex: Unknown