MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CUSHING BIPOLAR FCPS 7-1/4 BAY

Catalog Number 285187

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

Doctor initially reports he noticed burning smell when testing before usage.(b)(6) 2015, customer reports that the doctor was preparing to do a mastopexy.Doctor sensed the burning smell after a couple of seconds when testing device.No sparks or smoke observed.No patient contact, no harm done, no delay.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: CUSHING BIPOLAR FCPS 7-1/4 BAY
• Type of Device: NA
• Manufacturer (Section D): INTEGRA YORK, PA INC.; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise drive; 6099363828
• MDR Report Key: 4474246
• MDR Text Key: 5503675
• Report Number: 2523190-2015-00004
• Device Sequence Number: 1
• Product Code: EKS
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2015

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: 285187
• Device Lot Number: CG-0124
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 42 YR