MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR III LOW PROFILE SUCTION ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225361
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was received and evaluated.Visual observation under magnification revealed a small crack on the ceramic portion of the active tip at 7 o¿clock position.There was saline residue present in the suction tube, indicating the device had been used.The damage to the active tip is likely to be caused by the introduction of another metal instrument during the procedure.The instructions for use (ifu) state: ¿observe extreme caution when using electro surgery in close proximity to or in direct contact with any metal objects.The majority of arthroscopes and arthroscopic instruments are metal.Do not activate the electrode while any portion of the electrode and the adjacent metal object may result in product damage.¿ the electrode was connected to a vapr vue generator and all correct default settings were made available.The generator was set to maximum power for ablation and coagulation modes and activated in saline.There was no output from the electrode, confirming this complaint.When an electrode comes in contact with any metallic instrumentation or the scope in joint cavity, the generator will terminate activation and displays the warning ¿output shorted¿ with an alarm tone.This type of failure can be attributed to user technique issue.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Other than the possibility mentioned above, we cannot discern a root cause for this failure at this time.At this point, no corrective action is required and no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported that at the beginning of the procedure, a piece of the ceramic ring broke and the device couldn¿t work properly.It was noted the physician has used this type of device for many years.Additional information from the affiliate stated the pharmacist confirmed nothing fell into the patient.

• Brand Name: VAPR III LOW PROFILE SUCTION ELECTRODE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7747838
• Report Number: 1221934-2018-54302
• Device Sequence Number: 19152624
• Product Code: GEI
• UDI-Device Identifier: 10886705009381
• UDI-Public: 10886705009381
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2014

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 Catalogue Number: 225361
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2014
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1