MAUDE Adverse Event Report: STERILMED, INC.; CUT&COAG. ACCESS.,LAPARO & ENDO RPROCESD

Model Number COVLF4318

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was not able to reviewed as no lot number was given.

Event Description

It was reported that during a procedure, the device worked for a few minutes then would not move, the jaws did not operate freely, and subsequently ripped tissue.It was reported that there was no injury or consequence reported.Upon request for additional information it was reported that there was not excessive bleeding involved due to the device not properly sealing the tissue/vessels involved in the procedure.

• Type of Device: CUT&COAG. ACCESS.,LAPARO & ENDO RPROCESD
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: jason anderson ; 5010 cheshire parkway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 5535146
• MDR Text Key: 41491371
• Report Number: 2134070-2016-00018
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COVLF4318
• Device Catalogue Number: COVLF4318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 91