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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26FR
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KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26FR Back to Search Results
Model Number 27040GP1
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2022
Event Type  malfunction  
Event Description
It was reported that during a hystero resection, the loop broke 3 cm from its end as well as the wire.The ruptured part remained in the endometrium and required removal with hysteroscope forceps.No confirmation of injury or any adverse impact to the patient, user or third party reported.The broken part was retrieved with hysteroscope forceps.Internal karl storz reference number: (b)(4).
 
Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.
 
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Brand Name
CUTTING LOOP, BIPOLAR, 24/26FR
Type of Device
CUTTING LOOP
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key15695112
MDR Text Key302695053
Report Number2020550-2022-00297
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04048551393482
UDI-Public4048551393482
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 10/26/2022,10/28/2022
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
Device Operator Health Professional
Device Model Number27040GP1
Device Catalogue Number27040GP1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/26/2022
Event Location Hospital
Date Report to Manufacturer10/26/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/29/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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