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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 29100-BK
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KARL STORZ SE & CO. KG 29100-BK Back to Search Results
Model Number 29100-BK
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2020
Event Type  malfunction  
Event Description
It was reported that the plug fell off connection during surgery and was not found.The patient was subsequently x-rayed, but the piece could not be found.No further information was provided.
 
Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The affected component has been requested for investigation by the manufacturer.Component was not returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
29100-BK
Type of Device
29100-BK
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
Manufacturer Contact
christiane klaiber
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM   78532
MDR Report Key17714405
MDR Text Key323003214
Report Number9610617-2023-00246
Device Sequence Number1
Product Code LZU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number29100-BK
Device Catalogue Number29100-BK
Was Device Available for Evaluation? No
Date Manufacturer Received08/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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