MAUDE Adverse Event Report: ARTHROCARE CORP. UNKNOWN COBLATION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKNOWN

Device Problems Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694)

Event Date 11/22/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Paper name: articular cartilage and soft tissue damage from radiofrequency thermal ablation wands at wrist arthroscopy doi 10.1177/1753193420980347.

Event Description

It was reported that in the literature review "articular cartilage and soft tissue damage from radiofrequency thermal ablation wands at wrist arthroscopy"; was found a patient suffered a superficial (grade 2a) oblique burn over 1 cm at the 4-5 portal after a right wrist arthroscopy for ulnar-sided wrist pain procedure using a thermal coblation wand.Following the burn, the treating surgeon recalled that the shaft of the thermal wand had become quite hot during the operation.The burn ran proximally and obliquely from the 4-5 portal to the ulnar side of the wrist, indicating that it was caused by heat transmitted from the collar of the wand during debridement of the dorsal capsular synovitis radial to the portal.The burn healed with minimal scarring.Other than topical creams, the patient required no specific treatment.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.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.Per the complaint details, (study patients sited from a literature review), "articular cartilage and soft tissue damage from radiofrequency thermal ablation wands at wrist arthroscopy"; reportedly, ¿a patient suffered a superficial (grade 2a) oblique burn over 1 cm at the 4-5 portal.¿ additionally, it was reported the shaft of the thermal wand was ¿quite hot¿ during the procedure.Per complaint details, the burn was treated with ¿topical creams¿ (¿required no other specific treatment¿) and then ¿healed with minimal scarring.¿ per this journal article, ¿no other long-term problems were identified from the use of the thermal wand at 1 year postoperatively.¿ the images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.It has been communicated that no additional information is available.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported cannot be determined.Therefore, no further clinical/medical assessment can be rendered.There was no relationship found between the device and the reported event.Insufficient product identification information was provided and thus a manufacturing record, complaint history, instruction for use and risk management review could not be conducted.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: UNKNOWN COBLATION DEVICE
• 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: 15550215
• MDR Text Key: 301247496
• Report Number: 3006524618-2022-00435
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• 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?: No
• Date Manufacturer Received: 12/21/2022
• 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): Other
• Patient Age: 47 YR
• Patient Sex: Female