MAUDE Adverse Event Report: STERILMED, INC.; LAPAROSCOPE, GENERAL REPROCESSED

Model Number APPCTS02

Device Problem Fracture (1260)

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

Event Date 08/06/2014

Event Type  malfunction  

Event Description

It was reported that during a thorascopy the sleeve cracked once the trocar was placed inside of it.Another trocar sleeve was used to complete the procedure.This report is being filed for the findings upon device investigation.Add'l info was requested, but no add'l info was provided.A supplemental report will be sent if add'l info is received.

Manufacturer Narrative

Final device investigation found that the device was returned with grooves melted into the sleeve near the distal tip.Upon eval, the device was viewed under magnification, and no cracks were observed, the insufflation port and stopcock lever had sufficient friction to prevent unintended movement.The device passed the pin gauge test.The device was then pressure tested.The sleeve showed no signs of leaking when tested alone, but showed some signs of leaking when a test plug was inserted into the device.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: NA
• Type of Device: LAPAROSCOPE, GENERAL REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4239720
• MDR Text Key: 5074608
• Report Number: 2134070-2014-00186
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: APPCTS02
• Device Catalogue Number: CTS2
• Device Lot Number: 1761005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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