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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT; RIGID ENDOSCOPE WORKING GUIDE
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KARL STORZ SE & CO. KG WORKING ELEMENT; RIGID ENDOSCOPE WORKING GUIDE Back to Search Results
Model Number 26050E
Device Problem Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 01/11/2023
Event Type  Injury  
Event Description
It was reported that the patient had burns on the introitus vaginae (vestibulum) and an additional medical intervention was required.Additional patient information is not available.
 
Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
WORKING ELEMENT
Type of Device
RIGID ENDOSCOPE WORKING GUIDE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key16487179
MDR Text Key310715571
Report Number2020550-2023-00052
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04048551092293
UDI-Public4048551092293
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/02/2023,03/06/2023
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
Device Operator Health Professional
Device Model Number26050E
Device Catalogue Number26050E
Device Lot NumberNP01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/02/2023
Event Location Hospital
Date Report to Manufacturer03/02/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/06/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ZC_200948426: MATERIAL-NO: 26050NK, LOT-NO: P001; ZC_200948441: MATERIAL-NO: 26050NK, LOT-NO: Z001; ZC_200948444: MATERIAL-NO: 277, LOT.NO: RQ01
Patient Outcome(s) Required Intervention;
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