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

Model Number APPCTS02

Device Problem Leak/Splash (1354)

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

Event Date 06/30/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic cholecystectomy three devices leaked.Suction and irrigation was being used through at least one of the devices, which leaked whenever the instrument was inserted into it.At least one of the devices was not replaced.Visibility was "not good" because of the leaking.The case was completed.All three devices leaked to a certain extent.One device leaked more than the others.There was no patient injury.See related mfr reports 2134070-2014-00141 and 2134070-2014-00143.

Manufacturer Narrative

The device was retrieved from the user facility and is currently in transit to the manufacturer's testing facility.A supplemental report will be sent upon completion of device evaluation.

• Brand Name: NA
• Type of Device: NLM - 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: 4176903
• MDR Text Key: 5161414
• Report Number: 2134070-2014-00142
• 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: 06/30/2014

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 Model Number: APPCTS02
• Device Catalogue Number: CTS02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 49 YR