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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. BIPOLAR ELECTRODES; BIPOLAR CUTTING LOOP

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KARL STORZ GMBH & CO. BIPOLAR ELECTRODES; BIPOLAR CUTTING LOOP Back to Search Results
Model Number 26040GP1
Device Problems Material Separation (1562); Arcing of Electrodes (2289)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2014
Event Type  malfunction  
Event Description
Allegedly, the doctor was performing a small fibroid removal, but discovered during the case a very large, vascular myoma that had grown into the uterine wall.The doctor experienced difficulties in addressing this condition resulting in excessive bleeding, extended procedure time, a perforated uterus and hospitalization.During the procedure, the electrode arced and broke and the loop fell into the pt.The doctor retrieved the piece.The broken electrode did not cause the bleeding, extended procedure time, perforated uterus or hospitalization.
 
Manufacturer Narrative
It is possible that too much stress was applied to the electrode during use resulting in arcing and detachment of the loop.
 
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Brand Name
BIPOLAR ELECTRODES
Type of Device
BIPOLAR CUTTING LOOP
Manufacturer (Section D)
KARL STORZ GMBH & CO.
tuttlingen
GM 
Manufacturer (Section G)
KARL STORZ GMBH & CO. KG
mittelstrasse 8
tuttlingen
GM  
Manufacturer Contact
susie
2151 e grand ave
el segundo, CA 90245-5017
4242188201
MDR Report Key4298218
MDR Text Key15821265
Report Number9610617-2014-00059
Device Sequence Number1
Product Code HIN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122983
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/17/2014
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
Device Catalogue Number26040GP1
Device Lot Number48403
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/13/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/19/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
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