MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 4.0MM SUCT LGDIAM - EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225360
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2015
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.The complaint device was received and evaluated.Visual observation of the electrode reveals the distal tip shows signs of activation.There is tissue debris around the tip and saline solution stains on the device¿s surface.Under magnification, it was observed that the manifold shows signs of melting between 5 - 7 o'clock positions of the tip.This damage to the tip would lead to the sparking at the active tip, confirming this complaint.This device was not tested for safety reasons.The ifu states: ¿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.¿ no further information was provided to determine if the above mentioned factors contributed to this failure.Due to an increasing trend in the number of this reported failure, a supplier capa has investigated this failure.Root cause: the design is such that the operator requires a specific aptitude to ensure the glue wicks successfully this aptitude was not previously ensured by the electrode design.Corrective action: awareness retraining, clip application video retraining has been provided to the operators.This capa was monitored for its effectiveness and the complaint rate was below threshold, therefore initial training and awareness training was effective.A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.A review into the complaints system revealed no other complaints for this lot of devices that was released to distribution.Since the function of the electrode is to ablate tissue, the risk associated with sparking of the electrode tip within the joint space is low.However, depuy synthes 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.(b)(4).This report is being filed from the (b)(6) 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 during arcr the device did not perform vaporization.It was also reported that the surgeon found something like a spark from the tip of the device, so he stopped using the device.It was brand new and the first use when the issue occurred.By using a backup device, the surgery was completed successfully.There was no surgical delay or harm to the patient.

• Brand Name: VAPR 4.0MM SUCT LGDIAM - EA
• 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: 7796262
• Report Number: 1221934-2018-51210
• Device Sequence Number: 14040319
• Product Code: GEI
• UDI-Device Identifier: 10886705009374
• UDI-Public: 10886705009374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/10/2015

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: 225360
• Device Lot Number: U1501043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2015
• Initial Report FDA Received Date: 08/19/2018
• Patient Sequence Number: 1