MAUDE Adverse Event Report: STERILMED, INC.

Model Number ETH2B5LT

Device Problem Leak/Splash (1354)

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

Event Date 01/21/2014

Event Type  malfunction  

Event Description

It was reported that during a prostatectomy the device apparently failed to maintain insufflation during the procedure.Another device was used to complete the case.There was no pt injury.

Manufacturer Narrative

Final device investigation found that the device was returned in good visual condition.Upon evaluation, in an attempt to duplicate the event the device was pressure tested.The device showed no signs of leaking when the sleeve was tested alone and when the obturator was inserted into the sleeve.The device history record was reviewed, and not discrepancies were noted.As the device passed all visual and 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: tracia shrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 3753004
• MDR Text Key: 4465856
• Report Number: 2134070-2014-00031
• 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: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2014
• Device Model Number: ETH2B5LT
• Device Catalogue Number: 2B5LT
• Device Lot Number: 1726281
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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: 61 YR
• Patient Weight: 114