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

Model Number EIC8898-01

Device Problems Failure to Deliver Energy (1211); Suction Failure (4039)

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

Event Date 12/16/2021

Event Type  Injury  

Event Description

It was reported that during an adenotonsillectomy with debrider, the wand 'procise coblator max' was not working at all, the suction was not functional and the device was not cutting tissue.It is unknown if a backup device was available and how the issue was resolved.A delay greater than 30min took place and no further complications were reported.

Manufacturer Narrative

Internal complaint reference: case (b)(4).(b)(6).

Event Description

It was reported that during an adenotonsillectomy with debrider, the wand 'precise coblator max' was not cutting tissue and suction stopped.The procedure was completed by changing to cold steel technique.A delay greater than 30 minute took place and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H2: additional information in b5 (event description) and h6 (health impact code).

Manufacturer Narrative

H10: internal complaint reference: (b)(4).The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include: 1) the tissue attempted to be suctioned was too large, thereby causing a clog.2) insufficient suction pressure or saline flow to excavate tissue.3) electrode damage.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13146178
• MDR Text Key: 283145628
• Report Number: 3006524618-2022-00007
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470007473
• UDI-Public: 00817470007473
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K070374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2022
• Device Model Number: EIC8898-01
• Device Catalogue Number: EIC8898-01
• Device Lot Number: 2038612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention