MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME; NONE

Catalog Number 3539700

Device Problems Break (1069); Loss of Power (1475); Device Inoperable (1663); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the dermatome device was broken, there was no power and it won't turn on.It was reported the device was not in use for this event.There was no pt involvement.

Manufacturer Narrative

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

Manufacturer Narrative

This complaint was reported in duplicate by the customer.This complaint was reported as a product complaint.The repair request related to the product complaint was captured in a different complaint file and reported under mfg report number 3004608878-2015-00133.The investigation details for this device related event will be described in f/u mdr's for each initial report submitted.Integra has completed their internal investigation on june 12, 2015.Results: device history record reviewed for (b)(4) manufactured - 02/24/2010 show no abnormalities relate 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 this reported failure for this product id shows that (b)(4) complaints were received including this case.No new design or mfg trends have been identified.Failure analysis found that motor is inoperative due to corrosion and damaged cord.Conclusion: in summary, the end users reason for return was verified.The motor on the returned device was inoperative and the most likely cause could be due to corrosion and damage to the power cord.General maintenance is required as this device was manufactured in 2010 with no prior service history.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: NONE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4768679
• MDR Text Key: 5787708
• Report Number: 3004608878-2015-00144
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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