MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT; NONE

Catalog Number 3539250

Device Problems Sticking (1597); Failure to Auto Stop (2938)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident has been returned.The device evaluation is in progress.The result of the device evaluation will be reported in a follow up mdr submission.

Event Description

It was reported the device on/off switch is not working.The switch is stuck in the "on" position.It was reported there the device was not in use for this event.No patient involvement on injury is indicated.

Manufacturer Narrative

Integra completed its internal investigation (b)(6) 2015.The investigation included: method: dhr review.Complaint trend.Visual inspection.Results: device history record reviewed for 1-11574 manufactured on 08/06/2013 show no abnormalities related to reported incident found.This device passed all required inspection points with no associated mrr¿s, variances or rework.No previous service history on file.A two year look back for the reported failure and or related to "on/off switch is not working, it is stuck on the on position" for this product id shows that (b)(4) complaints were received including this case.No new design or manufacturing trends have been identified.Received hand piece only without a guard, no width clips or tools included with return.Head calibration is in tolerance on all points except knob tension-low, common with over use.Head also has grooved eccentric screws and minor nicks on the gauge bar both common wear.Corrosion found on all internal assemblies starting at the bottom of the motor casting down to the end cap including motor assembly.Switch does not function, and switch boot is torn from use.Reason for return confirmed, switch does not function.Also motor is corroded, the part passed amp test but future problems likely.Switch failure likely due to corrosion or moisture damage to the spring.Corrosion from moisture found inside the hand piece and could also have entered the switch through the cracked switch boot.Conclusion: the end users reason for return was verified.The most likely reason could be due to the corrosion found on all of the internal assemblies.

• Brand Name: MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT
• Type of Device: NONE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4996077
• MDR Text Key: 23938731
• Report Number: 3004608878-2015-00208
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3539250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1