MAUDE Adverse Event Report: ARTHROCARE CORP. UNKN COBLATION SPORTSMED DEV; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKN04300201

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

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Article citation:zou juan.(2016).Effects of different surgical methods on the immune function of children with obstructive sleep apnea syndrome (master's formation, shandong university).

Event Description

It was reported that on literature review effects of different surgical procedures on immunity of children with obstructive sleep apnes hypopnes syndrome, 1 patient had the tonsils significantly larger than before the operation(grade iii) after a tonsillectomy procedure using a coblation system, 1 other patient had post-operative bleeding after a tonsillectomy procedure using a coblation system.The patient with the increase in the size of the tonsils was submitted to another tonsillectomy, the other patient with the bleeding received bipolar electrocoagulation under general anesthesia to stop the bleeding.Patients outcome is not known.No further information is available.

Manufacturer Narrative

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.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed, and the root cause 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.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, instructions for use/device labeling review, historical escalation review, and risk management 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 data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/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.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 COBLATION SPORTSMED DEV
• 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: 13995674
• MDR Text Key: 288608612
• Report Number: 3006524618-2022-00170
• 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,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN04300201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• 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
• Patient Outcome(s): Required Intervention