MAUDE Adverse Event Report: DEPUY MITEK MITEK VAPR3 GENERATOR; ELECTROSURGICAL: CUTTING AND COAGULATING

Catalog Number 225021

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

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 04/30/2015

Event Type  Injury  

Event Description

It was reported that during arcr surgery, it was noted irregular pulse with the patient and his pulse stopped for a short time when the device was activated.It was brand new and the first use when the issue was happened.The device (electrode) was discarded at the hospital.By using the replacement, the surgery was completed without any delay.No further information is available at this point.(b)(6) will provide the details as received.Additional information received via email from our affiliate on 5-29-15 indicates the patient had no pre-existing medical conditions and is reported to be well.Additional information received via email from the service center on 6-5-15 indicates no problem was found with the vapr3 generator.Additional information received via email from our affiliate on 6-23-15 indicates the patient¿s heart may not have actually stopped, rather the monitor may have been affected by noise (interference) from the vapr which made it appear on the monitor like it had stopped.See associated medwatch # 1221934-2015-00803.

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.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.In process.

Manufacturer Narrative

The complaint device was received by our service center.The device underwent a visual, functional, and electrical test and revealed no anomalies.The reported failure could not confirmed and a root cause could not be determined.Further a review into the depuy mitek complaints system revealed 1 other dissimilar and 1 other similar complaints for this device.At this point in time, 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.

Event Description

It was reported that during arcr surgery, it was noted irregular pulse with the patient and his pulse stopped for a short time when the device was activated.It was brand new and the first use when the issue was happened.The device (electrode) was discarded at the hospital.By using the replacement, the surgery was completed without any delay.No further information is available at this point.Jjkk will provide the details as received.Additional information received via email from our affiliate on (b)(6) 2015 indicates the patient had no pre-existing medical conditions and is reported to be well.Additional information received via email from the service center on 6-5-15 indicates no problem was found with the vapr3 generator.Additional information received via email from our affiliate on (b)(6) 2015 indicates the patient's heart may not have actually stopped, rather the monitor may have been affected by noise (interference) from the vapr which made it appear on the monitor like it had stopped.See associated medwatch # 1221934-2015-00803.

• Brand Name: MITEK VAPR3 GENERATOR
• 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: eric so ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4872546
• MDR Text Key: 6264967
• Report Number: 1221934-2015-00844
• 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,company repres
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 225021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/30/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2015
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other