MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR PREMIERE50 ELECTRODE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number 227504

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the healthcare professional that during an unknown procedure, it was observed that the premiere50 electrode device did not work.A new hand piece was opened to complete the procedure.No patient consequences or surgical delay reported.During in-house engineering evaluation, it was determined that the device had no output; and that it would not ablate nor coagulate.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Product complaint #: (b)(4).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.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.Investigation summary: the device was sent to the suppler for evaluation.The supplier reports indicate: the active tip of the electrode does not show any signs of activation and appears to be in an out of box condition.There appears to be minor evidence of dried saline/liquid within the suction tube of the device.The electrode shaft, handle, cable and plug does not show any signs of damage.Electrical testing was performed and the hipot and return continuity tests passed.The active continuity and primary capacitance tests failed.Functional testing was performed and the connection display, default values, available waveforms, minimum and maximum settings available tests passed.Activation testing was done and the ablate and coag tests failed.The capacitance of the device was also found to be way out of specification, but the device was still recognised by the device.Closer inspection of the plug shows that the required capacitance specification is correct.The capacitor of the device is over molded into the plug, thus further investigation into the incorrect capacitance readings cannot be conducted.It can only be assumed that the capacitor is either damaged, or an incorrect capacitor has been used.During further inspection of the device to establish the continuity failures within the active circuit, an anomaly was noted on the active insulation exiting the distal end of the crimp.It was seen that the ¿black¿ outer insulation was missing.This anomaly noted on the active wire exiting the crimp did not result in the failure reported, but is a manufacturing error, and could result in a customer complaint.From the supplier investigation they were able to confirm the customer reported defect, the returned device was found to exhibit intermittent connection in continuity across the electrical crimp contained within the handle.A capa investigation cap was initiated to investigate the intermittent connection within the device handle which resulted in a design activity to improve the robustness of the dhr review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.No further information regarding the cause of the defect has been provided to help determine the actual root cause for this failure.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.Udi: (b)(4).

• Brand Name: VAPR PREMIERE50 ELECTRODE -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: 9524843
• MDR Text Key: 199312219
• Report Number: 1221934-2019-60170
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009923
• UDI-Public: 10886705009923
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 227504
• Device Lot Number: U1810144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1