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

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Date 05/01/2014

Event Type  Injury  

Event Description

It was reported that on literature review "the clinical research to tonsillectomy within capsule of tonsil by low-temperature plasma", 7 patients had a postoperative wound infection after a tonsillectomy procedure where a evac 70 coblation wand was used.It is unknown how were the events treated.Patients outcome is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference (b)(4).Article cite: sun yupeng, the clinical research to tonsillectomy wiehin capsule of tonsil by low-temperature plasma, master tesis.

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.A complaint history review found similar reported events.The complaint of infection cannot be confirmed from the provided images.Insufficient product identification information was provided and thus a manufacturing record 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.Insufficient product identification information was provided and thus a risk management review could not be conducted.The data presented in the aged article did not provide insight or relevance to current clinical outcomes for the product/device.Per subsequent e-mail, no further information is available.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome 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 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.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: 13976455
• MDR Text Key: 288372255
• Report Number: 3006524618-2022-00134
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• 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: 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): Other