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	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2016
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 electrode reveals the distal tip shows signs of activation.There is tissue debris around the tip and saline solution stains on the device¿s surface.Under magnification, it was observed that the manifold shows signs of severe melting between 4 - 9 o'clock positions of the tip.This damage to the tip would lead to the improper functioning of the electrode, confirming this complaint.This device was not tested for safety reasons.The ifu states: ¿observe extreme caution when using electro surgery in close proximity to or in direct contact with any metal objects.The majority of arthroscopes and arthroscopic instruments are metal.Do not activate the electrode while any portion of the electrode and the adjacent metal object may result in product damage.¿ no further information was provided to determine if the above mentioned factors contributed to this failure.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the complaints system revealed no other complaints for this lot of devices that was released to distribution.Since the function of the electrode is to ablate tissue, the risk associated with sparking of the electrode tip within the joint space is low.However, 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.(b)(4).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 by the affiliate in (b)(6) that during a shoulder procedure, it was observed that the tip vapr presented a short (burned) during articulation.The patient did not present any serious event.The procedure was completed with same like product.There was a 15 minute delay in the surgical procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 7872764
• Report Number: 1221934-2018-51632
• Device Sequence Number: 2050043
• Product Code: GEI
• UDI-Device Identifier: 10886705009381
• UDI-Public: 10886705009381
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial
• Report Date (Section B): 03/31/2016

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: 02/28/2018
• Device Catalogue Number: 225361
• Device Lot Number: U1503112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2016
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1