MAUDE Adverse Event Report: STERILMED, INC.

Model Number ETHMCM20

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

It was reported that during an anterior cervical discectomy and fusion c5-7, the device misfired and cut the neck vein completely through.This caused add'l time and resources to repair the vein before proceeding with the procedure.Another device was used to complete the procedure.Multiple attempts were made to obtain add'l info, but no add'l info was provided.A f/u report will be sent if add'l info is received.

Manufacturer Narrative

Final device investigation found that the device was returned in good visual condition.Upon eval.The device was cycled and fed and produced eight of the remaining nine clips with proper pinch and alignment.The sixth clip did not load properly into the jaws and was discharged unformed.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: NA
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia sharater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 3777788
• MDR Text Key: 4356803
• Report Number: 2134070-2014-00018
• Device Sequence Number: 1
• Product Code: NMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: ETHMCM20
• Device Catalogue Number: MCM20
• Device Lot Number: 1714112
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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 Age: 43 YR
• Patient Weight: 75