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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM 1 S 3D LAP, 0°
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KARL STORZ SE & CO. KG TIPCAM 1 S 3D LAP, 0° Back to Search Results
Model Number 26605AA
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2024
Event Type  Injury  
Event Description
It was reported that the device started flickering during use which cause a delay of 15 to 60 mins.Furthermore, according to the information received, the procedure could not be completed successfully, since the final inspection of the operating area could not take place.
 
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).
 
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Brand Name
TIPCAM 1 S 3D LAP, 0°
Type of Device
TIPCAM
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key18669637
MDR Text Key334950252
Report Number2020550-2024-00032
Device Sequence Number1
Product Code FGB
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 02/08/2024
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 Number26605AA
Device Catalogue Number26605AA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/07/2024
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer02/08/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/08/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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