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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 24/26FR BIPOLAR CUTTING LOOP

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KARL STORZ SE & CO. KG 24/26FR BIPOLAR CUTTING LOOP Back to Search Results
Model Number 26040GP1-S
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
Event Type  malfunction  
Manufacturer Narrative
Follow-up was made to obtain more information; however, the reporter did not have additional regarding the issue.Reported device was returned for evaluation.Once the evaluation is complete, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).
 
Event Description
It was reported that the biopolar cutting loop broke at the tip.At the end of the procedure, a nurse realized that the bipolar cutting loop had a piece missing at the tip.The physician was able to retrieve the portion that had broken off inside the patient.There was no report of injury to the patient.No additional information was available.
 
Manufacturer Narrative
The reported device was evaluated.Per visual evaluation, the active electrode has broken off on one side and the second connecting bar has been completely torn out of the embossing.One possible cause for this is that, for example, the electrode was used without activating the hf current.This resulted in excessive tensile forces acting on the cutting wire, which caused the wire to be pulled out.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
24/26FR BIPOLAR CUTTING LOOP
Type of Device
24/26FR BIPOLAR CUTTING LOOP
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
anja fair
2151 e grand ave.
el segundo, CA 90245
4242188247
MDR Report Key18297433
MDR Text Key330143524
Report Number9610617-2023-00391
Device Sequence Number1
Product Code HIN
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 User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 02/27/2024
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 Number26040GP1-S
Device Catalogue Number26040GP1-S
Device Lot Number37AC4949
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2023
Initial Date Manufacturer Received 11/16/2023
Initial Date FDA Received12/08/2023
Supplement Dates Manufacturer Received02/01/2024
Supplement Dates FDA Received02/27/2024
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
Patient Outcome(s) Required Intervention;
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