MAUDE Adverse Event Report: DEPUY MITEK MITEK VAPR PREMIERE 90 DEGREE SUCTION ELECTRODE; ELECTROSURGICAL: CUTTING AND COAGULATING

Catalog Number 227204

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

Patient Problem Burn(s) (1757)

Event Date 05/09/2015

Event Type  Injury  

Event Description

It was reported that during arcr the patient got blister(s) caused by a mild burn around the shoulder while the surgeon was using the device without suctioning.The rep remind the doctor to use the suction for circulation of saline for control temperature.It was brand new and the first use when the issue occurred.The backup device was used to complete the case.There was no surgical delay.The patient is now under observation.The following additional information was received via email from our affiliate on 7-2-15; the surgeon did not treat the patient¿s burn.The surgeon did not use the device suction line at all, it was not connected to the wall suction.A pump was used in the procedure with other devices like a scope and shaver.

Manufacturer Narrative

The complaint device is not being returned, therefore is unavailable for a physical evaluation.A review of the product¿s instructions for use revealed the following warnings; ensure that fluid inflow and outflow is adequate and that the electrode is activated only when surrounded by conductive irrigant solution (e.G., saline or ringer¿s lactate).The use of rf energy with inadequate irrigation may overheat the fluid enough to cause skin burns at or near the access site and may result in damage to the electrode tip assembly.Failure to attach the suction tubing to an adequate suction source may cause thermal injury to the physician or patient.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our 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 (b)(4) devices that were released to distribution.We cannot discern a root cause for the reported failure mode, although a possible root cause is the suction tube of the electrode was not connected as warned against in the product¿s instructions for use.At this point in time, no corrective action is required and no further action is warranted.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.

• Brand Name: MITEK VAPR PREMIERE 90 DEGREE 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: 4903484
• MDR Text Key: 6539629
• Report Number: 1221934-2015-00860
• 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: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 227204
• Device Lot Number: U1408103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/11/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2015
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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
• Patient Outcome(s): Other