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	Not Applicable (3189)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.Investigation summary: the complaint device was received and evaluated.Visual inspection revealed the active tip shows signs of activation and the manifold is melted between 3 ¿ 6 o¿clock positions of the tip.To avoid further damage, a functional test was not conducted on the device.However, the damage to the active tip could lead to the reported failure, confirming this complaint.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 records reviewed.Further, a review of the depuy synthes mitek complaints system revealed two dissimilar complaints for this lot of devices released to distribution.Due to an increasing trend of this failure, a supplier investigation was initiated to investigate this issue further.A mitek non-conformance was opened for this issue, and is now closed.The issue was also being investigated via a mitek data review which is also closed.The device was manufactured and released prior to the investigation of this capa.The root cause was found to be that the electrode design relies on the epotek adhesive to provide a dielectric barrier between active and return path.The internal tracking distance is shorter than the external; therefore if the epotek layer breaks down, internal activation can occur with resulting sparking and arching.As identified by previous capa, the occurrence rate of the capa failure mode can be reduced to an acceptable level by increasing the aptitude of the operator, by providing awareness of the capa failure mode and also by making sure that the training video is watched in conjunctions with the relevant assembly aids.This can be further improved by changing the training requirement when assembly aids are updated to a repeat training requirement on a 6 month basis.Depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.(b)(6).(b)(4).
Event or Problem Description
It was reported that the devise was used for the arthroscopic rotator cuff repair surgery to remove soft tissue or stop bleeding on (b)(6) 2018.It was reported that the probe could not function suddenly, such as short-circuits (output shotted, 1 sec reset).The surgeon replaced the probe (same p/n, lot number was unknown) to complete the surgery.After the surgery, surgeon noticed that the probe tip (ceramic cover) was broken.The surgeon checked the broken fragment which was suspected to remain the patient¿s body under x-ray, but there were no broken parts found in the patient¿s body.It was brand new and the first use when the issue occurred.There was less than 30min.Surgical delay and no harm to the patient.

• 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: 7677608
• Report Number: 1221934-2018-53361
• Device Sequence Number: 1370316
• 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): 06/11/2018

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: 07/31/2019
• Device Catalogue Number: 225361
• Device Lot Number: U1608146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/11/2018
• Patient Sequence Number: 1