MAUDE Adverse Event Report: GYRUS ACMI, INC. BERKELEY VC VACUUM CURETTAGE SYSTEMS

Model Number VC-2

Device Problem Pumping Stopped (1503)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/09/2015

Event Type  Injury  

Event Description

Olympus received a voluntary medwatch which stated, "a patient was undergoing a dilation and curettage (d&c) in the operating room (or).The suction pump was only working intermittently and then the pump stopped working.An or nurse picked up the power cord to see if the device was plugged in.The machine turned back on and a humming noise was heard.The operating room nurse then grabbed the cord to pull out of the wall and the cord caught on fire.The nurse sustained a 2nd degree burn to her hand.The patient was not injured." olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the report but was unsuccessful.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information or if the device is received at a later time, this report will be supplemented.

• Brand Name: BERKELEY VC VACUUM CURETTAGE SYSTEMS
• Type of Device: VACUUM CURETTAGE SYSTEMS
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4857203
• MDR Text Key: 5847402
• Report Number: 2951238-2015-00271
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VC-2
• Device Catalogue Number: VC-2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other