MAUDE Adverse Event Report: STERILMED, INC. AUTO SUTRE; ENDOSCOPIC TROCAR

Model Number AUTNB12STF

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 12/12/2013

Event Type  malfunction  

Event Description

It was reported that the device fell apart upon insertion, leaking gas, took top off - gasket (ring) fell out.Another device was used to complete the procedure.There was no pt injury.

Manufacturer Narrative

Final device investigation found that the device was returned with the gasket separate from the sleeve of the device.There were no cuts or tears on the gasket.The obturator was returned in good visual condition.Upon evaluation, the gasket was assembled back onto the sleeve and the sleeve was pressure tested.The sleeve showed signs of leaking when the obturator was inserted.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: AUTO SUTRE
• Type of Device: ENDOSCOPIC TROCAR
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 3770291
• MDR Text Key: 4444245
• Report Number: 2134070-2014-00004
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043592
• 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: 12/17/2013

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: 08/01/2014
• Device Model Number: AUTNB12STF
• Device Catalogue Number: NB12STF
• Device Lot Number: 1681554
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/30/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2014
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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: 52 YR