MAUDE Adverse Event Report: STERILMED, INC.; ELECTROSURGICAL, CUTTING & COAGULATION REPROCESSED

Model Number COVLF1637

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer as of the date of this report.A supplemental report will be sent after the device evaluation if the device is received.No lot number was reported so the device history record could not be reviewed for discrepancies.

Event Description

It was initially reported that the surgeon was complaining about the functionality of the device.Upon request for additional information, it was reported that the grasper was sticky and difficult to remove from tissue that it had been used on.It was also reported that the device jaws were sticking to tissue.There was no patient injury or harm.Another device was opened and the procedure was completed.

• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: patricia kaufman ; 5010 cheshire parkway; suite 2; plymouth, MN 55446 ; 7634888321
• MDR Report Key: 5070306
• MDR Text Key: 25536305
• Report Number: 2134070-2015-00043
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COVLF1637
• Device Catalogue Number: COVLF1637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1