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

Catalog Number UNKN04300100

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

Patient Problem Pulmonary Embolism (1498)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Article cite: zhang qf, song w, she cp, liu dl, li dw, zhang xr, cheng c.[coblation-assisting uvulopalatopharyngoplasty combining coblation-channeling of the tongue for patients with severe osahs].Lin chung er bi yan hou tou jing wai ke za zhi.2012 feb;26(3):114-7.Chinese.Doi: 10.13201/j.Issn.1001-1781.2012.03.013.Pmid: 22506427.

Event Description

It was reported that on literature review "the clinical significance of the anatomy of palate and tongue in coblation-assisting hanuvulopalatopharynoplasty combining radiofrequency ablation of the tongue in patient with severe osahs", one patients had a postoperative pulmonary artery embolism 10 days after a han-uvulopalatopharyngoplasty using a reflex 55 wand, an evac 70 wand and coblator ii surgery system.No further treatment reported.Patient outcome is unknown.No further information is available.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).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 no similar reported events.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 from china was translated and the information was provided on an expanded excel spreadsheet.However, it did not provide insight or relevance to current clinical outcomes for the product/device.Based on the information provided, no further information is available.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.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 ENT 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: 13995776
• MDR Text Key: 288495894
• Report Number: 3006524618-2022-00162
• 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,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

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: UNKN04300100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• 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): Required Intervention