MAUDE Adverse Event Report: DEPUY MITEK MITEK VAPR LOW PROFILE SUCTION ELECTRODE; ELECTROSURGICAL: CUTTING AND COAGULATING

Catalog Number 225361

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2015

Event Type  malfunction  

Event Description

It was reported that during arcr the device sparked inside the joint.It was brand new and the first use when the issue occurred.The device was connected vapr 3.It is not known that how long it took before the issue was noted.It was discarded at the hospital.By using a backup device, the surgery was completed successfully.No surgical delay or harm to the patient was reported.

Manufacturer Narrative

The complaint device is not being returned for evaluation and therefore the reported failure cannot be verified.It cannot be determined what type of damage the active tip sustained that led to this type of failure.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 available to determine if the above mentioned factors contributed to this failure.A batch record review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.The complaint rates were reviewed against the risk analysis documents and found to be within expected levels.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.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.

• Brand Name: MITEK VAPR LOW PROFILE SUCTION ELECTRODE
• Type of Device: ELECTROSURGICAL: CUTTING AND COAGULATING
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4881317
• MDR Text Key: 20038064
• Report Number: 1221934-2015-00847
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 225361
• Device Lot Number: U1411123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/03/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2015
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1