MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 4.0MM SUCT LOPROFILE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225361
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only one device was returned was returned.The device was sent to the supplier for evaluation.The device shows signs of use as there is some procedural debris/saline residue around the distal tip.There is some procedural debris remaining within the suction hole of the active tip.The remainder of the device appears to be in a good condition.A flow test was then performed on the device using the suction unit, digital scales, a stopwatch, a glass beaker and saline solution.The returned device was attached to a suction unit via the enteral adaptor.The suction unit was set to -700mmhg and the device was immersed in saline.Over the course of 1 minute the device extracted 326ml of saline, which is slightly in excess of the 100 to 300ml criteria detailed in the design specification.The 100 to 300ml limit is for the device in a 'brand new' state.Activation of the device can cause the suction hole in the active tip to wear and therefore increase flow rate above the initial specification.The electrode was connected to a vapr vue generator to test its functionality.The generator recognized the electrode and all correct default settings were displayed.The electrode tip was placed in a beaker of saline and the device passed the cut and coag functional tests.The device passed all functional tests and the reported fault could not be replicated.It may be that during the return process the cause of the initial blockage has become dislodged.A dhr 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 two dissimilar complaints for this lot of 296 devices that were released to distribution.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.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported that aspiration was defective with 2 electrodes.Used 3rd one.No patient consequences.Please see also medwatch report 1221934-2018-52638.

• Brand Name: VAPR 4.0MM SUCT LOPROFILE -EA
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7899501
• Report Number: 1221934-2018-52637
• Device Sequence Number: 19181236
• Product Code: GEI
• UDI-Device Identifier: 10886705009381
• UDI-Public: 10886705009381
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 225361
• Device Lot Number: U1605072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2016
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1