MAUDE Adverse Event Report: ARTHROCARE CORP. EVAC 70 XTRA HP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EIC5874-01

Device Problem Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference : (b)(4).

Event Description

It was reported that, during a tonsillectomy , the evac 70 xtra hp icw was found to be clogged.The procedure was completed with a competitor's device (bonss) with a delay of less than or equal to 30 min.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future re-occurrence of the reported event.Please refer to the instructions for use for recommendations on clogged devices.A review of risk management files found that the reported failure was documented appropriately.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: EVAC 70 XTRA HP COBLATOR II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11256334
• MDR Text Key: 229576362
• Report Number: 3006524618-2021-00115
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470004595
• UDI-Public: 00817470004595
• Combination Product (y/n): N
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EIC5874-01
• Device Catalogue Number: EIC5874-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other