MAUDE Adverse Event Report: CONMED CORPORATION AES-90SN PROBE ASSY,SUCT,SIN; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number AES-90SN

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation of the reported complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.The manufacturing documents from the device history record have been reviewed and found a ncr however it is not related to the reported event.Additionally, no abnormalities were found that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu the user is also 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.If partial coverage of the return electrode is required for the procedure, use a lower setting and maintain visibility of the return electrode while applying rf.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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, conmed (b)(4) received notification of an issue involving the aes-90sn probe, lot # 202012211 that occurred at (b)(6) on (b)(6) 2021.It was reported only that during a shoulder scope procedure, the silver face plate came off while the instrument was being used.It is indicated the procedure was successfully completed using another edgeablator.There was no impact or injury to the patient.Although requested, no clarification was made available.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: AES-90SN PROBE ASSY,SUCT,SIN
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: tracey weiselbenton ; 11311 concept blvd; largo, FL 33773-4908 ; 7273995557
• MDR Report Key: 11661158
• MDR Text Key: 249502020
• Report Number: 1320894-2021-00179
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)251220(10)202012211
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AES-90SN
• Device Catalogue Number: AES-90SN
• Device Lot Number: 202012211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1