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

Model Number MODEL S

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the device was working intermittently.The device required a tap on the hand piece to get it to run.It was reported the device was not in contact with the patient for this event.No patient involvement or injury is reported.

Manufacturer Narrative

Integra has completed their internal investigation on 9jun2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: device history record reviewed for this product id serial # (b)(4) manufactured on september 16, 2008 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.No manufacturing or design related trend has been identified.In summary: reason for return confirmed, found non-oem parts including open frame power supply, motor and sleeve bearing.There was 6.5 years since last pm service.Complete failure of all internal assemblies due to parts, corrosion, damage.Handle needs actuator rod / handle upgrade.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; 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: 5620887
• MDR Text Key: 44725130
• Report Number: 3004608878-2016-00097
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

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 Model Number: MODEL S
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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