MAUDE Adverse Event Report: ARTHROCARE CORP. TBD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888)

Event Date 01/04/2019

Event Type  Injury  

Event Description

It was reported in a social network, that only five days after tonsil surgery, when the scabs fell off, the patient's blood vessels were not closed, if the patient had not been awake he could have bled to death.

Manufacturer Narrative

Updated information.The device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.It is possible that the suction pressure at the customer¿s facility may have not supplied enough pressure in order to excavate blood and tissue which will cause the tip to clog; therefore, decreasing the functionality of the wand, health and the patient's compliance to post-op instructions, or certain medicines and/or bleeding disorders that are known to reduce the body¿s ability to clot.Post-tonsillectomy bleeding is a known common occurrence of the procedure.There is no patient data provided, and the device has not been returned for evaluation.The information provided is insufficient to determine the exact cause of the bleeding.Therefore, the exact root cause of the repeated bleeding cannot be determined at this time, and the patient's current condition is unknown.

• Brand Name: TBD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8287204
• MDR Text Key: 134443072
• Report Number: 3006524618-2019-00040
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other