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

Catalog Number 227204

Device Problems Suction Problem (2170); Unknown (for use when the device problem is not known) (2204)

Patient Problem Burn(s) (1757)

Event Date 04/10/2015

Event Type  Injury  

Event Description

Patient was operated for arthroscopy of the right shoulder.At the end of the procedure, a redness occurred on her forearm.After the surgery, occurrence of a burn on another surface of 15cm * 5cm at the forearm.Dressing + biafine.Information of the patient.Recommendation for enforcement biafine and monitoring at home.Consultation with the surgeon to follow the (b)(6) 2015.The following additional information was received via email from our affiliate on (b)(6) 2015; according to the sales rep who met the surgeon and the o.R.Nurse last week, the patient is fine.The burn is quite important but the patient¿s shoulder is ok.The surgery is successful and the patient is well.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.

Manufacturer Narrative

The complaint device is not being returned, therefore is unavailable for a physical evaluation.The product instructions for use states; ¿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.¿ the ifu also states ¿for electrodes with suction, attach the suction adapter to standard hospital suction equipment.Ensure that the roller clamp is open, and vacuum is in the range of 300 mmhg to 700 mmhg.¿ 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 one possible root cause is inadequate irrigation / suction resulting in the patient burn from overheating of fluid.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.

Event Description

Patient was operated for arthroscopy of the right shoulder.At the end of the procedure, a redness occurred on her forearm.After the surgery, occurrence of a burn on another surface of 15cm * 5cm at the forearm.Dressing + biafine.Information of the patient.Recommendation for enforcement biafine and monitoring at home.Consultation with the surgeon to follow (b)(6) 2015.The following additional information was received via email from our affiliate on may 22, 2015; according to the sales rep who met the surgeon and the o.R.Nurse last week, the patient is fine.The burn is quite important but the patient's shoulder is ok.The surgery is successful and the patient is well.The following additional information was received from our affiliate on june 3, 2015; the patient's burn was only located on the patient's forearm.The electrode was new and used a maximum of 20 minutes.The suction tube of the electrode was connected.The customer was using an arthroscopic pump from arthrex for suction.

• 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: 4815999
• MDR Text Key: 15129492
• Report Number: 1221934-2015-00810
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,company repres
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 227204
• Device Lot Number: U1412017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/07/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2015
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2015
• 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