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

Catalog Number 3539700

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that on (b)(6) 2017, a 3539700 padgett model s slimline electric dermatome had stopped working.The device was tried to be used but it stopped again.The procedure was discontinued and there was a delay in the procedure more than half of the day.The procedure was completed by borrowing another machine from another hospital.No patient injury were reported.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.Dhr reviewed for s-855 shows no abnormalities relate to reported incident found nor where there any variances, mrr¿s or reworks associated with this serial numbers.Dhr provided by oem shows no evidence of service history on file.Excess time in service.Sampling plan reviewed and is acceptable.As the instrument was not returned for examination, no definitive root cause could be determined.If the device will be returned at a later date this complaint will be reopened and an analysis will be performed.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 7369342
• MDR Text Key: 103808972
• Report Number: 3004608878-2018-00042
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• 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?: No
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1