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

Model Number APPCTS02

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported that the device leaked.Another device was used to complete the procedure.There was no pt injury.Add'l info was requested, but no add'l info was received.A supplemental report will be sent if add'l info becomes available.

Manufacturer Narrative

Final device investigation found that the device was returned in good visual condition.Upon eval, it was determined that the deep cone seal was torn.The insufflation port and stopcock lever were securely fastened and had sufficient friction to prevent unintended movement.The device was then pressure tested and showed signs of leaking when a test plug was inserted into the device.No lot number was provided, so the device history record could not be reviewed.As each device is inspected prior to release, no conclusion could be made as to what may have caused the reported event.

• Brand Name: NA
• 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: 4174973
• MDR Text Key: 5098983
• Report Number: 2134070-2014-00152
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/14/2014

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: Other
• Device Model Number: APPCTS02
• Device Catalogue Number: CTS02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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