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 06/20/2014

Event Type  malfunction  

Event Description

It was reported that during an appendectomy the device leaked "excessively." it was unclear whether the leaking was from the port or the cannula itself.Another device was used to complete the procedure.There was no pt injury.Additional info was requested, but no additional info was provided.

Manufacturer Narrative

Final device investigation found that the device was returned in good visual condition.Upon evaluation the obturator passed all visual inspection.The handle and distal tip were securely fastened, and the obturator fully and smoothly inserted into the sleeve.The sleeve's insufflation port and stopcock lever were securely fastened and had sufficient friction to prevent unintended movement.The sleeve was then pressure tested.The sleeve showed no signs of leaking when tested by itself, but showed signs of leaking when the obturator was inserted into the sleeve.The device history record was reviewed, and no discrepancies were noted.

• 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: 3979338
• MDR Text Key: 4815808
• Report Number: 2134070-2014-00139
• 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: 06/23/2014

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: 02/01/2015
• Device Model Number: APPCTR73
• Device Catalogue Number: CTR73
• Device Lot Number: 1730733
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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