MAUDE Adverse Event Report: STERILMED, INC.

Model Number COVLF4200

Device Problems Failure to Align (2522); Mechanical Jam (2983)

Patient Problem Blood Loss (2597)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

It was reported that during a radical cystectomy the device malfunctioned with tissue engagement.The blade jammed and the jaws misaligned, which caused bleeding.The bleeding continued as had to wait for another device to be opened and set up.It was not reported whether the jaws were stuck on pt tissue.No injury was reported.Additional info was requested, but no additional info was provided.A follow-up report will be sent if additional info is received.

Manufacturer Narrative

Final device investigation found that the device was returned to the mfr with the connector cut off.The jaws of the device appeared to be in alignment and were able to fully open and close as intended.The main handle was able to latch and unlatch, and the trigger, switches and levers were easy to operate.The blade was able to actuate and release freely.The device jaws were viewed under the magnification and it was found that there were two long straight gouge marks running diagonally near the tip of one side of the jaws and several smaller marks on the edges of the metal plate.The device history record was reviewed, and no discrepancies were noted.As the device passed all visual and mechanical functional testing, no conclusion could be made as to what may have caused the reported event.

• Brand Name: NA
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 3972887
• MDR Text Key: 4633993
• Report Number: 2134070-2014-00085
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: COVLF4200
• Device Catalogue Number: LF4200
• Device Lot Number: 1746644
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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