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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.; BIPOLAR CUTTING LOOP

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KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR.; BIPOLAR CUTTING LOOP Back to Search Results
Model Number 27040GP1
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/09/2021
Event Type  Injury  
Manufacturer Narrative
Device was not returned for investigation.No available result yet.
 
Event Description
As per a manufacturer incident report we received from the factory in (b)(6): on (b)(6) 2021, during a surgical intervention, the bipolar resection loop again separated at the level of the yellow fixation systems.The material is lost between the bladder and the urethra with risks of perforation.
 
Manufacturer Narrative
Upon investigation, it could be confirmed that the loop was bent.Also, at the breaking point of the loop, it can be seen that the wire has melted; this could potentially have been caused by a short circuit when the electrode came too close to the neutral electrode during use.The root cause is most likely due to mechanical overload, i.E.User error.No indication for material or manufacture defect found during investigation.Ifu already included a warning that a mechanical overload can provoke a potential risk for the patient.
 
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Brand Name
CUTTING LOOP, BIPOLAR, 24/26 FR.
Type of Device
BIPOLAR CUTTING LOOP
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM 
MDR Report Key11863538
MDR Text Key251975410
Report Number9610617-2021-00045
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04048551393482
UDI-Public4048551393482
Combination Product (y/n)N
PMA/PMN Number
K061541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/23/2021
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? No
Device Operator Health Professional
Device Model Number27040GP1
Device Catalogue Number27040GP1
Device Lot NumberSP38
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/23/2021
Initial Date FDA Received05/21/2021
Supplement Dates Manufacturer Received04/23/2021
Supplement Dates FDA Received07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
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