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

Model Number	27294AA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is to correct the entire initial report.The wrong report was accidentally submitted under (b)(4).This supplemental report is the correct report that accurately reflects the events that took place.The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that during fifth surgery the vision got lost.It was found that objective lens detached from tip.The procedure abandoned.
Additional Manufacturer Narrative
New information was provided that alters the reportability of this event from reportable to non-reportable.No event (timeframe: between 2021-09-30 and 2023-11-16) that could be considered as similar to this one and caused or contributed to a death or serious injury could be found.In conclusion, the risk for serious deterioration in state of health is negligible.Thus, a report is not required.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
More detailed information received: the lens was out but attached to the scope.The procedure was completed successfully with prolongation of 5-6min.

• 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
• 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 90245
• MDR Report Key: 18066539
• Report Number: 9610617-2023-00339
• Device Sequence Number: 7814931
• 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): 11/20/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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