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

Catalog Number AES-90SN

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been received into conmed's complaint system 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

Conmed received notification from the facility of an issue involving the aes-90sn aes-90 degree probe suct.Sn, lot # 202102041 that occurred at melville surgery center on (b)(6) 2021.The information received was that during a right shoulder arthroscopy, the tip of the wand fell apart while the instrument was being used.It is indicated the procedure was successfully with a 2 minute delay.There was no impact or injury to the patient and all pieces were recovered.To date, although multiple attempts have been made to gather additional information, no information has been provided.This reporting is being raised as a device malfunction with potential for injury upon reoccurrence, as although removed, the tip did fall off into the patient.

Manufacturer Narrative

Investigation of the customer's reported issue and complaint was confirmed based on evaluation of the returned device.A visual examination of the returned used device, item aes-90sn confirmed the reported problem, and found device electrode broken off.The broken piece was not returned per evaluation.The examination was performed per edge probes, standard work line #1 documents.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A 2-year lot history review was conducted and found no other similar events reported for this lot number.(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 advised do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering.If any visual damage or defects are noticed during use, stop using the device immediately and replace the device.Use care when inserting into and withdrawing the probe from a cannula or tissue portal to avoid the possibility of damage to the devices and/or injury to the patient.Do not insert, withdraw or touch the active tip of the probe when power is being applied.This may result in an unintended surgical effect, injury, or device damage".The ifu also advises the user to always maintain the active probe tip in the field of view.Injuries to the patient may result from inadvertent activation or movement of an activated probe outside the field of view.Do not activate the electrode while any portion of the electrode tip 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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AES-90 DEGREE PROBE SUCT. SN
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 11642477
• MDR Text Key: 260994536
• Report Number: 1320894-2021-00183
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: K153499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

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 Number: AES-90SN
• Device Lot Number: 202102041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 05/26/2021
• Patient Sequence Number: 1