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 Problem Post Operative Wound Infection (2446)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Article: liu shaofeng, huang guiliang, huang zhenyun, sun changzhi, & luo renzhong.(2021).Partial tonsillectomy for the treatment of 86 children with obstructive sleep apnoea syndrome.Journal of otolaryngology, shandong university, 35(2), 50-54.

Event Description

It was reported that on literature review partial tonsillectomy for 86 cases of obstructive sleep apnea syndrome in children, 4 patients had an infection after a tonsillectomy procedure where a coblator ii was used.It is unknown how the event was resolved and the patient outcome.No further information is available.

Manufacturer Narrative

H10 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 review, complaint history review, risk management review, and an instructions for use/device labeling 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.A clinical review states that based on a review of the provided literature article, the device will not be returned, and no further information will be provided.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause of the infection and/or the outcome of the four of patients beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.There was no relationship found between the device and 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: 15357578
• MDR Text Key: 299282250
• Report Number: 3006524618-2022-00392
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• 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
• Date Manufacturer Received: 10/10/2022
• 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): Other