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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 27040GP1/6
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The affected device has been requested for investigation by the manufacturer.Device was returned for investigation.Evaluation findings: missing distal cutting loop, discolored loop, melted yellow insulation and burnt connection prongs.The event is filed under internal karl storz complaint id: (b)(4).
 
Event Description
It was reported that the loop broke off in the patient during the procedure.
 
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Brand Name
CUTTING LOOP, BIPOLAR, 24/26 FR.
Type of Device
CUTTING LOOP, BIPOLAR, 24/26 FR.
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
Manufacturer (Section G)
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 Key18067951
MDR Text Key327318768
Report Number9610617-2023-00349
Device Sequence Number1
Product Code FAS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K221893
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 11/03/2023
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 Number27040GP1/6
Device Catalogue Number27040GP1/6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2022
Initial Date Manufacturer Received 10/16/2023
Initial Date FDA Received11/03/2023
Was Device Evaluated by Manufacturer? Yes
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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