MAUDE Adverse Event Report: ARTHROCARE CORP. UNKN COBLATOR II SURGERY SYSTEM AND WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Vomiting (2144)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Analysis of collation complications in children with obstructive sleep apnea-hypopnea syndrome 10.6040/j.Issn.1673-3770.0.2017.533.

Event Description

It was reported that on literature review analysis of coblation complications in children with obstructive sleep apnea-hypopnea syndrome, 17 patients complications after a tonsil procedure using a coblator ii surgery system with evac 70 or integrated evacxtrahp coblation wand.12 patients had wound bleeding of tonsil after surgery with vomiting, from which surgical hemostasis was require d(2 cases were admitted to picu after surgery, 1 of which was treated with blood transfusion, and another case was rescued due to vomit suffocation during anesthesia before hemostasis), 5 other patients had a perforation due to defective palatopharyngeal arch tissue, from which 2 patients with the maximum diameter of perforation of 0.3-0.6 cm, were not treated because of the absence of symptoms, and the other 3 patients healed on their own within 2 months.All patients were discharged successfully.No further information is available.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record, complaint history, risk management and capa, nc, pra/hhe review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.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.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: UNKN COBLATOR II SURGERY SYSTEM AND WAND
• 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: 14002717
• MDR Text Key: 288594043
• Report Number: 3006524618-2022-00184
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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