MAUDE Adverse Event Report: DEPUY MITEK LLC US LPS (LOW-PROFILE SUCTION) ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225361
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and evaluated.Visual observation of the active tip indicates signs of activation.There is evidence of melting at the 3 o'clock section of the manifold.There is nothing physically broken on the tip or insulation as reported.There is only a crack on the manifold of the tip.No functional test was conducted to avoid further damage.A batch record review has been conducted and 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 mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.A capa has been initiated at the supplier to investigate and determine a root cause for this failure.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 remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).
Event or Problem Description
It was reported that the product stopped working soon after the surgery had started.It seemed that the tip of the probe was broken.When the probe was replaced to another product and connected to the same vapr 3 system, there was no problem and completed the case.Nothing was left in the patient.The probe used at the surgery was brand new device.The surgeon was expert with this device and the incident was occurred for the first time at the hospital.

• Brand Name: LPS (LOW-PROFILE SUCTION) ELECTRODE
• 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: 7789942
• Report Number: 1221934-2018-51818
• Device Sequence Number: 11371114
• Product Code: GEI
• UDI-Device Identifier: 10886705009381
• UDI-Public: 10886705009381
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/06/2013

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: 01/31/2016
• Device Catalogue Number: 225361
• Device Lot Number: M1302013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2013
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1