MAUDE Adverse Event Report: ARTHROCARE CORP. PROCISE MAX COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EICA8898-01

Device Problem Suction Problem (2170)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that during an adenoidectomy, it was reported that the surgeon was unable to successfully ablate down the tissue without massive clogging and bleeding in order to remove the adenoids.The case took over 1.5 hours where it should¿ve taken about 30 minutes.No patient injury was reported.The procedure was completed with a competitor device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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.The impact to the patient beyond the reported bleeding and the procedural delay cannot be determined.Should an additional medical information be provided, this compliant would be re-assessed.Therefore, no further clinical/medical assessment is warranted at this time.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.A review of the instructions for use found monitor saline flow during procedure.A review of risk management files found that the reported failure was documented appropriately.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 reoccurrence of the reported event.Factors that could have contributed to the reported event include: not having sufficient saline outflow in order to maintain coagulation or possibly not having sufficient suction which decreases the functionality of the device.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Internal complaint reference: (b)(4).

• Brand Name: PROCISE MAX COBLATOR II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10694693
• MDR Text Key: 211851919
• Report Number: 3006524618-2020-00894
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003888
• UDI-Public: 00817470003888
• Combination Product (y/n): N
• PMA/PMN Number: K070374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EICA8898-01
• Device Catalogue Number: EICA8898-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 15 YR