MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

Catalog Number 3539700

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the dermatome device had intermittent power loss.It was reported there was no patient involvement for this event.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; reason for return is not confirmed, unit tested with good amperage but motor was mildly corroded.Dhr review; device history record reviewed for s-143 manufactured 01-29-2010 show 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 in may of 2015 for "not calibrating" complaints history; a two year look-back in trackwise for this reported failure and related to "issues with power " for this product id shows that (b)(4) complaints were received including this case.Conclusion: in summary the end users reason for return could not be duplicated as the returned unit passed all functional testing requirements.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: NA
• 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 ; 6099362341
• MDR Report Key: 5011824
• MDR Text Key: 24230636
• Report Number: 3004608878-2015-00216
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/22/2015

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: 08/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2010
• 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