MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR S90 4.0MM W/INTEGR HDP -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number 225370

Device Problems Loss of or Failure to Bond (1068); Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Incomplete the expiration date is unknown.

Event Description

It was reported by the sales rep via phone that during an unknown procedure on an unknown date when the customer's vapr s90 electrode 4.0mm with integrated handpiece was plugged into the generator, it was recognized but would not work at all.The procedure was completed with another electrode from a different lot with the same generator.There was no patient harm or surgical delay to the case reported.The sales rep was not present for the case therefore could not provide any further details.The device will be returning for evaluation.In house evaluation of the returned device found that the electrode had an output short occurred when using the ablation function and no output occurred when the coagulation function was activated.The electrode was sent to the supplier for an in-depth investigation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Date of event is an unknown date in 2019.Reporter is a mitek employee.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The complaint device was received and an evaluation was performed.Visual observation revealed the active tip showed signs of being activated in the past, and no saline residue was seen in the suction tube.There were no anomalies found on the device.The device was connected to a test vapr vue generator to test the functionality of the device.The device was activated in both ablate and coag modes for several seconds; however an output shorted error occurred during ablate, and coag had no function.The complaint device was forwarded to the manufacturer for further investigation of the observed failures.The manufacturer¿s investigation substantiated the customer¿s claim that the device would not work, confirming the complaint.A break in continuity across the electrical crimp in the handle was discovered.Relevant actions have been taken.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VAPR S90 4.0MM W/INTEGR HDP -EA
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9343943
• MDR Text Key: 208150930
• Report Number: 1221934-2019-59600
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009398
• UDI-Public: 10886705009398
• Combination Product (y/n): N
• PMA/PMN Number: K122425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 225370
• Device Lot Number: U1901077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 11/22/2019
• Patient Sequence Number: 1