MAUDE Adverse Event Report: CONMED CORPORATION ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18CM; ARTHROSCOPIC PROBE

Model Number	AES-50SL
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is confirmed.Examination of the returned used device, item aes-50sl,found plastic heat shrink tube damaged.See attached photo.Appears the black pet shrink used to cover the outer return tube has been torn by rubbing and contact with a hard object causing failure of the insulation.Evidence appears to indicate the pet material exhibits wear lines and traces of being rubbed against another object.This is not a manufacturing defect.Examination was performed per edge probes, standard work line.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 were 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.A two-year review of complaint history revealed there has been 3 complaints regarding 3 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; maintain the active probe tip 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 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.
Event or Problem Description
The distributor reported on behalf of their customer that the aes-50sl, arthroscopic probe cover on the shaft was peeling during use in a procedure.There was no patient or user injury or impact reported.There was no surgical delay reported.This report is being raised based on device malfunction with the potential for injury upon reoccurrence.

• Brand Name: ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18CM
• Common Device Name: ARTHROSCOPIC PROBE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8784331
• Report Number: 1320894-2019-00228
• Device Sequence Number: 1689565
• Product Code: GEI
• UDI-Device Identifier: 10653405004974
• UDI-Public: (01)10653405004974(17)190923(10)201803271
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2019
• Device Model Number: AES-50SL
• Device Catalogue Number: AES-50SL
• Device Lot Number: 201803271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1