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

Model Number ETHH12LP

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

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

Event Date 06/10/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic cholecystectomy the device leaked.The "part of the trocar that suture is tied to broke off and was retrieved," another device opened.It appeared that the device broken when the tubing was connected.The procedure was paused while the parts of the device were retrieved, but no pieces of the device fell into the patient.There was no alteration in the outcome, and no patient injury.

Manufacturer Narrative

Final device investigation found that the device was returned with one of the suture stays on the stability cone detached and returned with the device.Upon examination under magnification, it was found that one of the locking tabs on the suture stay had broken off and was not returned with the device.It also was noted that there was a crack inside the sleeve and on the stopcock.The device sleeve was then pressure tested for leaking.The sleeve showed no signs of leaking when tested by itself, but did show signs of leaking when an obturator was inserted into the sleeve.No lot number was provided, so the device history record could not be reviewed for discrepancies.

• 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: 4162647
• MDR Text Key: 4784859
• Report Number: 2134070-2014-00136
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052299
• 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: 06/18/2014

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: ETHH12LP
• Device Catalogue Number: H12LP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/16/2014
• 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
• Patient Age: 55 YR
• Patient Weight: 47