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

Model Number COVLF1637

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the device was "sticking" with coagulation and cutting being needed more than usual.Additional information was received that the procedure was a hysterectomy and it was reported that the first procedure of burn and cut went as planned, the device was not cleaned and sent for a second burn which is where the device stuck to tissue, not cauterizing the tissue.The procedure was completed with a triverse and hook.No tones were heard.There was no patient injury or blood loss.Additional time was needed to complete the procedure.It was reported that the jaws were not cleaned after each use or during the procedure at all.No more force than recommended was used.

Manufacturer Narrative

The device was not returned to the manufacturer as of the date of this report and was reported to be discarded by the user facility.No lot number was reported so the device history record could not be reviewed for discrepancies.

• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION, LAPAROSCOPIC & ENDOSCOPIC, 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: 4837949
• MDR Text Key: 5944207
• Report Number: 2134070-2015-00029
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• 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: 05/26/2015
• 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