MAUDE Adverse Event Report: COVIDIEN STEP SHORT INSUFFLATION/ACCESS NEEDLE; NEEDLE, INSUFFLATION

Catalog Number S110000

Device Problems Complete Blockage (1094); No Flow (2991)

Patient Problem No Information (3190)

Event Date 06/23/2014

Event Type  malfunction  

Event Description

During a laparoscopic chole, the insufflation needle was not infusing the co2 gas.Doctor reported that the insufflation needle was "clogged".He made several attempts to reposition the needle before asking the circulator to open another insufflation needle.The second needle worked without incident and the case resumed.This incident resulted in about a ten minute delay of the case.

• Brand Name: STEP SHORT INSUFFLATION/ACCESS NEEDLE
• Type of Device: NEEDLE, INSUFFLATION
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 3973278
• MDR Text Key: 18037722
• Report Number: 3973278
• Device Sequence Number: 1
• Product Code: HIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 06/24/2014

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: Invalid Data
• Device Catalogue Number: S110000
• Device Lot Number: J4A1036X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1