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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED UTICA SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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CONMED UTICA SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number 60-5274-032
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2022
Event Type  malfunction  
Event Description
Conmed japan reported on behalf of their customer that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs), was being used during an unknown procedure on (b)(6) 2022 when it was reported, ¿the insulating part was peeled off when removing the scorched part of the tip during surgery.It was retrieved the insulating piece that has fallen into the abdominal cavity.The collected insulation part is in the white glove which is returned.¿ the procedure was completed with another unknown device.Further assessment questioning found that there was no patient or user impact.There was no extended hospitalization or medical/surgical intervention needed for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Manufacturer Narrative
Received one 60-5274-032 in unoriginal package.Lot number was not verified.Performed a visual inspection, the complaint was confirmed.The tip of the electrode was peeling.A two-year lot history review could not be completed as a lot number was not provided.A device history record review could not be conducted as a lot number was not provided.(b)(4).Per the instructions for use, the user is advised the following: this product is designed for non-continuous operation, with a duty cycle of 10 seconds on, and 30 seconds off.Always use the lowest possible setting to achieve the desired electrosurgical effect.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
Conmed japan reported on behalf of their customer that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs), was being used during an unknown procedure on (b)(6) 2022 when it was reported, ¿the insulating part was peeled off when removing the scorched part of the tip during surgery.It was retrieved the insulating piece that has fallen into the abdominal cavity.The collected insulation part is in the white glove which is returned.¿ the procedure was completed with another unknown device.Further assessment questioning found that there was no patient or user impact.There was no extended hospitalization or medical/surgical intervention needed for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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Brand Name
SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS)
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
CONMED UTICA
525 french rd
utica NY 13502
Manufacturer (Section G)
CONMED UTICA
525 french rd
utica NY 13502
Manufacturer Contact
robin drum
11311 concept blvd
largo, FL 33773
8653881978
MDR Report Key15700982
MDR Text Key306902917
Report Number1320894-2022-00221
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K952204
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/09/2022
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 Catalogue Number60-5274-032
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/17/2022
Initial Date FDA Received10/31/2022
Supplement Dates Manufacturer Received11/15/2022
Supplement Dates FDA Received12/09/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Patient Sequence Number1
Patient EthnicityNon Hispanic
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