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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR.
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KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR. Back to Search Results
Model Number 27040GP1
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2024
Event Type  Injury  
Event Description
It was reported that "the tip of the loop separated and fell into the patients bladder".As a result, the procedure was delayed between 15 and 60 minutes.According to the information available, the procedure was completed successfully.No harm to patient, user or third reported.
 
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
CUTTING LOOP, BIPOLAR, 24/26 FR.
Type of Device
CUTTING LOOP
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key19203841
MDR Text Key341295157
Report Number2020550-2024-00123
Device Sequence Number1
Product Code FAS
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/29/2024
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 Number27040GP1
Device Catalogue Number27040GP1
Device Lot NumberWM36
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/26/2024
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer04/29/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/29/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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