MAUDE Adverse Event Report: COVIDIEN YANKAUER RGD OPEN W/O TROL

Model Number 8888505115

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a yankauer.The customer reports that the yankauer tip broke off into a patient.Medical intervention required the patient to undergo anesthesia to irrigate the area in order to find and remove the broken piece.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.Several attempts to gather information from the customer were made to date, no additional information has been received.If additional pertinent information becomes available, the report will be updated.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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.The current molding process conditions were reviewed and it was confirmed that all manufacturing procedures are being followed properly.The most probable root cause can be due to resin degradation during the molding process.A quality alert was performed and the manufacturing personnel were made aware of the reported issue.The time period for preventative maintenance of the molding process was reduced to prevent any potential risk.This complaint will be used for tracking and trending purposes.

• Brand Name: YANKAUER RGD OPEN W/O TROL
• Type of Device: YANKAUER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4642317
• MDR Text Key: 16563967
• Report Number: 9612030-2015-00035
• Device Sequence Number: 1
• Product Code: JOL
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888505115
• Device Catalogue Number: 8888505115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1