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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 07/26/2023
Event Type  malfunction  
Event Description
The customer reported that the device, aes-90sn, aes-90sn probe assy,suct,sin, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿when ongoing use at medium power the probe broke on the upper side, and the round metallic disc got misassembled.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.Further reporting from the user states, ¿the broken tip of the vaporizer was easily and totally removed from the joint cavity.¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Manufacturer Narrative
The device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified.The manufacturing documents from the device history record (dhr) have been reviewed with special attention to the manufacturing and inspection of the product.Although a non-conformance was found in the dhr, it was not related to this failure mode.The product released for distribution was found to have met all specifications prior to shipment.A 2 year lot history review shows a total of 3 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 65 complaints, regarding 67 devices, for this device family and failure mode.During this same time frame 210,657 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0003.Per the instructions for use, the user is advised to not 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.Alternate site ablation may occur if 75% of the return electrode is masked, making the return electrode surface area smaller than that of the active 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 customer reported that the device, aes-90sn, aes-90sn probe assy,suct,sin, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿when ongoing use at medium power the probe broke on the upper side, and the round metallic disc got misassembled.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.Further reporting from the user states, ¿the broken tip of the vaporizer was easily and totally removed from the joint cavity.¿.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 Key17539468
MDR Text Key321046260
Report Number1320894-2023-00158
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K153499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAES-90SN
Device Lot Number202303201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2023
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Age30 YR
Patient SexMale
Patient EthnicityNon Hispanic
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