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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PRISMATIC LIGHT DEFLECTOR

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KARL STORZ SE & CO. KG PRISMATIC LIGHT DEFLECTOR Back to Search Results
Model Number 10101JA
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/26/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
 
Event or Problem Description
It was reported that holding pin and spring popped out of the prismatic light deflector while being attached to a laryngoscope.No negative impact in state of health reported.
 
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Brand Name
PRISMATIC LIGHT DEFLECTOR
Common Device Name
PRISMATIC LIGHT DEFLECTOR
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, deu 78532 ,
GM  78532,
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, deu 78532 ,
GM   78532,
Manufacturer Contact
anja fair
2151 e. grand avenue
el segundo, CA 90245
4242188247
MDR Report Key24575754
Report Number9610617-2026-00526
Device Sequence Number21421517
Product Code EOQ
UDI-Device Identifier04048551045268
UDI-Public04048551045268
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K943700
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,User Facility,Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/11/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number10101JA
Device Catalogue Number10101JA
Device Lot NumberNU01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2026
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/03/2026
Initial Report FDA Received Date03/11/2026
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 Number1
Patient Age8 YR
Patient SexFemale
Patient Weight18 KG
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