MAUDE Adverse Event Report: STERILMED, INC. ENDOPATH BLADELESS TROCAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number 2B5LT

Device Problem Leak/Splash (1354)

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

Event Date 12/21/2016

Event Type  malfunction  

Event Description

Valve leaks, we were unable to retain inflation of the operative area.Sleeves (2) were replaced with non-reprocessed sleeves.

• Brand Name: ENDOPATH BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave. n.; sute 100; maple grove MN 55369
• MDR Report Key: 6338765
• MDR Text Key: 67670226
• Report Number: 6338765
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2B5LT
• Device Catalogue Number: 2B5LT
• Device Lot Number: 1915659
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2017
• Event Location: Other
• Date Report to Manufacturer: 02/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR