MAUDE Adverse Event Report: MITG - KENMEX KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711006
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 15-jun-2017.
Event or Problem Description
According to the reporter, during the procedure while opening the package, the nurse noted that the stylet was locked inside the tube, making it impossible to use the probe.
Additional Manufacturer Narrative
A device history record review could not be performed because the reported lot number was invalid.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.A root cause could not be determined.A corrective action is not applicable at this time.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
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): MITG - KENMEX; calle 9 sur no. 125 cuidad; tijuana,na 92173 ; MX 92173
• MDR Report Key: 6644356
• Report Number: 9612030-2017-05108
• Device Sequence Number: 979044
• Product Code: KNT
• UDI-Device Identifier: 10884521518780
• UDI-Public: 10884521518780
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 8884711006
• Device Catalogue Number: 8884711006
• Device Lot Number: 531480364X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1