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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY BIPOLAR CUTTING LOOP

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KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY BIPOLAR CUTTING LOOP Back to Search Results
Model Number 26040GP1
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2017
Event Type  malfunction  
Manufacturer Narrative
The electrode has not been returned for evaluation.
 
Event Description
Allegedly, during a myomectomy procedure the doctor noted that the loop broke and fell into the patient.He did an x-ray and the results were negative.They searched through suctioned fluid and found it there.The hospital reported there was no injury to the patient.
 
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Brand Name
BIPOLAR CUTTING LOOP
Type of Device
BIPOLAR CUTTING LOOP
Manufacturer (Section D)
KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
mittlestrasse 8,
78503
tuttlingen, germany,
GM 
Manufacturer (Section G)
KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
mittlestrasse 8,
78503
GM  
Manufacturer Contact
susie chen
2151 e. grand avenue
el segundo, CA 90245-5017
4242188519
MDR Report Key6714374
MDR Text Key80060442
Report Number9610617-2017-00055
Device Sequence Number1
Product Code HIN
UDI-Device Identifier04048551392720
UDI-Public4048551392720
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/15/2017
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 Physician
Device Model Number26040GP1
Device Catalogue Number26040GP1
Device Lot Number53497
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/15/2017
Initial Date FDA Received07/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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