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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & Co. KG FLEXIBLE INTUBATION SCOPE 3.5MM X 65CM
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KARL STORZ SE & Co. KG FLEXIBLE INTUBATION SCOPE 3.5MM X 65CM Back to Search Results
Model Number 091361-01
Medical Device Problem Code Poor Quality Image (1408)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/13/2026
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that image interference and distortion occurred during a procedure (two different scoped from same box).Flexing the tip worsened the image quality and made visualization of the area of interest difficult for the veterinarian.The procedure was prolonged by more than 30 minutes but less than 60 minutes.
 
 
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Brand Name
FLEXIBLE INTUBATION SCOPE 3.5MM X 65CM
Common Device Name
FLEXIBLE INTUBATION SCOPE 3.5MM X 65CM
Manufacturer (Section D)
KARL STORZ SE & Co. KG
dr.-karl-storz-strasse 34
tuttlingen 78532
GM  78532
MDR Report Key50675726
Report Number2020550-2026-02123
Device Sequence Number10398228
Product Code CAL
UDI-Device Identifier04048551422533
UDI-Public04048551422533
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/08/2026
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 Number091361-01
Device Catalogue Number091361-01
Device Lot Number500133091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/08/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
Material: 091361-01.Batch/Lod code: 500133091.
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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