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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR.
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KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR. Back to Search Results
Model Number 27294AA
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Insufficient Information (4580)
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.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.
 
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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
MDR Report Key18060115
Report Number2020550-2023-00339
Device Sequence Number15409754
Product Code FAJ
UDI-Device Identifier04048551233825
UDI-Public4048551233825
Combination Product (Y/N)N
Initial Reporter CountryIN
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/02/2023
Report Date (Section F) 11/01/2023
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 Number27294AA
Device Catalogue Number27294AA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/31/2023
Event Location Hospital
Date Report to Manufacturer11/01/2023
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/02/2023
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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