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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED UTICA AES-90SN PROBE ASSY,SUCT,SIN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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CONMED UTICA AES-90SN PROBE ASSY,SUCT,SIN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number AES-90SN
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2023
Event Type  malfunction  
Event Description
The sales representative reported on behalf of the customer that the aes-90sn, aes-90sn probe assy,suct,sin, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿an aes¿90sn tip came off outside a patient after being used.The tip was recovered.".There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported 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.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Manufacturer Narrative
Examination of the returned used device found the electrode detached from the probe tip.Detached electrode was not returned per evaluation.Additionally, the lot number was not verified.A likely cause of the event is due to contact with another metal object during the procedure.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: not to use the probe for mechanical displacement of tissue, damage to the probe may occur.The ifu also advises the user to maintain the probe tip, including the return electrode, in the field of view at all times.Injuries to the patient may result from inadvertent activation or movement of an activated probe outside the field of view.Care should be taken in procedures that may cover the probe return electrode.Do not activate the probe while any portion of the active or return electrode is in contact with another metal object, including the scope; localized heating of the electrode and the adjacent metal object may result in product damage and/ or injury.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Event Description
The sales representative reported on behalf of the customer that the aes-90sn, aes-90sn probe assy,suct,sin, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿an aes¿90sn tip came off outside a patient after being used.The tip was recovered.".There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
 
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Brand Name
AES-90SN PROBE ASSY,SUCT,SIN
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
john berga
11311 concept blvd
largo, FL 33773
7273995358
MDR Report Key18066776
MDR Text Key327305045
Report Number1320894-2023-00245
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAES-90SN
Device Lot Number202308021
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received12/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2023
Is the Device Single Use? Yes
Patient Sequence Number1
Patient EthnicityNon Hispanic
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