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

Model Number ETH2CB5LT

Device Problem Leak/Splash (1354)

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

Event Date 09/08/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic j-tube placement of two device sleeves leaked co2 and causing a loss of pneumoperitoneum.The device was leaking form the top.For one or both devices, a prestige was inserted into the device but after it was noticed to be leaking.No torque was being placed on the device.Another device was used to complete the procedure.There was no patient injury.See related mfr report #2134070-2014-000174.

Manufacturer Narrative

The device has not been received at the manufacturer's facility as of the date of this report.A supplemental report will be sent following investigation after the device is received.

• Type of Device: LAPAROSCOPE, 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: 4152560
• MDR Text Key: 4928771
• Report Number: 2134070-2014-00173
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121240
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: ETH2CB5LT
• Device Catalogue Number: 2CB5LT
• Device Lot Number: 1789249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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