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

Model Number APPCTR73

Device Problem Leak/Splash (1354)

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

Event Date 08/07/2014

Event Type  malfunction  

Event Description

It was reported that during the case, the device without the obturator leaked gas at seal (losing surgical view) and became a problem when the stapler and tissue pouch were inserted, as it caused them to get "hung up" on each other.The device was not replaced.There was no pt injury.

Manufacturer Narrative

Final investigation found that the returned device was a model appcts22.The device was in good visual condition.Upon eval, a tear was found on the deep cone seal.Upon pressure testing, the device showed no signs of leaking when tested by itself, but 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 all devices are 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: 4098361
• MDR Text Key: 4698188
• Report Number: 2134070-2014-00164
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APPCTR73
• Device Catalogue Number: CTR73
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• 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