MAUDE Adverse Event Report: CONMED CORPORATION AES-90SN PROBE, ASSY, SUNCTION, SIN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number AES-90SN

Device Problem Material Fragmentation (1261)

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

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been 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.

Event Description

On behalf of the customer, the conmed representative reported an issue involving the aes-90sn probe, lot # 202010191 that occurred at (b)(6) on (b)(6) 2020.It was reported only that during surgery the electrode broke off and there was no impact or injury to the patient.Additional information clarified the procedure was a shoulder arthroscopy with rotator cuff repair and biceps tenodesis.After approximately 3 minutes, during subacromial decompression, the staff thought the probe was clogged because it looked like there was a piece of tissue in the suction port.When they looked closer, they realized it looked like metal.They removed the probe from the patient, and it appeared as if the piece where the suction port would be cut out was not fully removed.They attempted to remove the piece of suction port, so they could have suction and the electrode broke in half.There were no fragments to be removed from the patient, as the probe broke outside of the patient (not while actively being used in the patient.) this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Conmed received two used aes-90sn.The lot number could not be verified.A visual examination of the returned used device found the electrode of one of the returned devices not inserted to the tip of the probe.The detached electrode was not returned for the evaluation.Examination was performed per edge probes, standard work line.Although the reported problem of broken probe was confirmed, a root cause was not established.The manufacturing documents from the device history record and lot history record have been reviewed and found no abnormalities that would contribute to this issue.A lot history review was conducted and found this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 24 complaints, regarding 25 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.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.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.Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 50/60 hz.The ifu also advises the user to not use the probe for mechanical displacement of tissue as damage to the probe may occur.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AES-90SN PROBE, ASSY, SUNCTION, SIN
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 11102374
• MDR Text Key: 225353399
• Report Number: 1320894-2020-00561
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K153499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AES-90SN
• Device Lot Number: 202010191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1