MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 386100

Device Problem No Display/Image (1183)

Patient Problem No Information (3190)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/20/2018.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that when they plugged in the tube, the tube lights up, but the console screen is blacked out with no visualization.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reported that when they plugged in the tube, the tube lights up, but the console screen is blacked out with no visualization.¿ all device history records (dhr) are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7447529
• MDR Text Key: 106193280
• Report Number: 1282497-2018-00296
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

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: 386100
• Device Catalogue Number: 386100
• Device Lot Number: 10884521164987
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1