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

Catalog Number 3539700

Device Problems Self-Activation or Keying (1557); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the dermatome device turns on and off whenever it wants to.No patient impact information has been provided.Additional information has been requested.

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

Integra has completed their internal investigation on june 19, 2015.Results: device history record reviewed for (b)(4) manufactured 12/15/2003 showed no abnormalities relate to reported incident found.This device passed all required inspection points with no associated mrr's, variances or rework.This device was last serviced on 03/31/2015.A two year look-back for this reported failure for this product id shows that 4 complaints were received including this case.No new design or manufacturing trends have been identified.Conclusion: in summary, the end users reason for return could not be verified as the device in question passed all functional test requirements.An inservice is being recommended with focus to the proper method of reprocessing as it was discovered that bearings on the returned device were oil depleted.

• 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: 4766345
• MDR Text Key: 5953247
• Report Number: 3004608878-2015-00139
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2003
• 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