MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.L.R KM7 TUBING, INSUF W/ .1 MICR FILT, ECONOMY; INSUFFLATION TUBING, TBING W/FILTER

Catalog Number 28-0207

Device Problem Material Distortion (2977)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

Customer reported that the lumen of the filter was much smaller than other filters.This was noticed when there was an issue with the intake of co2 during a laparoscopic procedure.

Manufacturer Narrative

This report is being filed due to a retrospective review of complaints.This complaint has been re-opened for filed for further investigation.A supplemental report will be filed if further investigation provides information which changes the content of this report.The filter was returned as was visibly damaged as shown through side-by-side comparison with other filters.The product was significantly damage, but the root cause could not be determined.Potential causes could be damage during shipment/storage, user error, improper storage.

• Brand Name: TUBING, INSUF W/ .1 MICR FILT, ECONOMY
• Type of Device: INSUFFLATION TUBING, TBING W/FILTER
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.L.R KM7; autopista joaquin balguer; pisano free zone, building 49; santiago ; DR
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 4759427
• MDR Text Key: 5954467
• Report Number: 3004605321-2015-00011
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2014,04/30/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 28-0207
• Device Lot Number: 27812113
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/30/2014
• Initial Date FDA Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other