MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC PLASMABLADE 3.0S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number PS210-030SE

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

Approximately 2.5 hours into use, the coating on the device tip started peeling off.The peeling was identified while the coating was still intact and none of the coating detached from the device or fell into the patient.There was no impact or injury to the patient.During analysis of the returned device on (b)(6) 2015 an additional failure was found.It was identified that the heat shrink was melted, split and detached.

Manufacturer Narrative

Product event# (b)(4).Investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade¿ 3.0s product number: pe210-030se lot number: 0208637503 - fl50810520 expiration date: 2017-05-31 quantity returned: 2 testing performed: device packaging inspection: -two plasmablade¿ 3.0s devices received inside a fedex shipper box with no packaging to fill the negative space and not within biohazard bags.-devices were labelled as device # 1 and device # 2 for traceability.-device # 1 ¿ (pli #20 in gch) failure to connect received inside the original display box with tyvek® lid included and within a single biohazard bag.-device# 2 ¿ (pli #30 in gch) peeling coating received inside the original display box and within two biohazard bags.-the device information for both devices was confirmed against the information listed within gch.-no paper work was included.Device visual inspection: device # 1: plasmablade¿ 3.0s - failure to connect -device appears used with dried blood on body, suction tubing and cord.-there are two bent, flattened and sheared device plug connector pins which visually relate to the reported complaint description, all other components appear in place and intact.-both cut and coag buttons have a definitive tactile feel.Device # 2: plasmablade¿ 3.0s ¿ peeling coating -device is used with dried blood on body, handle, shaft, nose and suction tubing.-suction tubing is taped to the device cord.-liquid blood and other biological fluids within the suction tubing lines.-blood and other biological fluids present along the inner shaft.-electrode coating is damaged with excessive electrode charring present which visually relates to the reported complaint description, figure # 3 thru figure # 6.-additionally the heat shrink is completely melted, split and detached as well as the suction opening is completely occluded with eschar and tissue build-up, figure # 3 thru figure # 7.-both cut and coag buttons have a definitive tactile feel.Functional inspection: device # 1: plasmablade¿ 3.0s - failure to connect -the plasmablade¿ 3.0s was attempted to connect to the complaint lab pulsar® ii generator however all attempts were unsuccessful.-the device plug connector pins would not line up with the receptacle on the generator, the screen displayed dashes for settings and there was no audible tone heard coming from the generator which confirms there was not a successful connection.-there are two bent, flattened, and sheared device plug connector pins along with several misaligned pins which prevent connection to the generator, pin # 5 and pin # 6, figure # 1.Device # 2: plasmablade¿ 3.0s ¿ peeling coating -not performed as the reported complaint was confirmed via visual inspection.Lhr review: a review of the lhr for lot # 0208637503 and lot # fl50810520 revealed there were no problems during manufacturing that can be associated with the reported complaint description.Investigation conclusion: device# 1: plasmablade¿ 3.0s - failure to connect complaint confirmed: the reported issue contained in gch was duplicated in the laboratory environment.Visual and functional inspection of the device plug connector pins confirmed that the device could not be connected to the complaint lab pulsar® ii generator successfully.A likely cause of the failure is the device plug connector has bent, flattened and sheared pins which prevent connection to the receptacle on the generator resulting in the device¿s failure to operate as expected.This failure mode could occur from rough handling during manufacturing testing, during use or misalignment of the pins at the connector manufacturer.The complaint will be tracked and trended in gch.Device # 2: plasmablade¿ 3.0s ¿ peeling coating complaint confirmed: the reported issue contained in gch was confirmed in the laboratory environment.Visual inspection confirmed that the insulation coating on the electrode is peeling and additionally the heat shrink is melted, split and detached from of the electrode and pushed over the electrode tip.The excessive eschar and tissue build-up on the electrode and within the suction opening likely caused the insulation coating to become compromised resulting in the peeling of the tip coating.Such devices are quality inspected prior to release to the customer, therefore it is likely that any damage to the electrode insulation coating would have been detected during manufacturing assembly, testing or during inspection.An excessive build-up of tissue results in the overheating and melting of the heat shrink.The rf energy is affected by gunk build-up and causes a change to the electrical path causing the energy to be directed to the tissue attached to the device rather than to the patient.When the energy path is directed to the tissue on the heat shrink, the component experiences high temperature and over time, it is possible for the heat shrink to degrade.The complaint will be tracked and trended in gch.A likely cause of the failure plausibly suggests the electrode was not cleaned according to the ifu recommendations during use, as evidenced by the excessive eschar, tissue build-up, melted and detached heat shrink as well as condition the device was returned in, which compromised the insulation coating and caused it to peel and flake off.Customers are properly trained for proper use prior to using the peak surgery system which includes reading and understanding the ifu.The ifu outlines proper cleaning and use of the plasmablade¿ and specifically relates to the reported complaint as listed below: lbl-00166 rev.C ¿ plasmablade¿ 3.0s ¿ ifu ¿ precautions and warnings -when bending the blade do not exceed a 45° angle.Do not bend more than three times.Excessive bending of the shaft may compromise performance of the device or cause device failure, which could result in patient or user injury.Use finger forces to bend the blade do not use forceps as this could damage the device.-unless the product is being used to spot coagulate a vessel, it is recommended to keep the electrode tip in motion while activated to avoid excessive eschar buildup.Excessive eschar buildup can compromise device performance.-do not use sharp or abrasive instruments or materials to clean eschar buildup on the electrode tip as this may damage the tip.-prior to use, inspect the peak plasmablade for any defects.Do not use if insulation or connectors are damaged.-take care when handling the electrode tip to prevent possible damage to the tip and to prevent user injury.-eschar buildup on the tip can be removed manually with gloved fingers or gauze pads, or by inserting the tip into the slot at the front of the holster and drawing the device backwards through the slot.Inspect the device for any signs of damage after cleaning.¿ -activation of the hand piece simultaneously while aspirating fluid may alter the path of electrical energy away from target tissue.(b)(4).

• Brand Name: PLASMABLADE 3.0S
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer Contact: kaylee boisvert ; 180 international drive; portsmouth, NH 03801 ; 6038426234
• MDR Report Key: 4764455
• MDR Text Key: 5777175
• Report Number: 1226420-2015-00082
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: PS210-030SE
• Device Catalogue Number: PS210-030SE
• Device Lot Number: 0208637503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00038 YR
• Patient Weight: 95