MAUDE Adverse Event Report: ARTHROCARE CORP. UNKN COBLATOR II SURGERY SYSTEM AND WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKN04300102

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

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Article citation: zhang hl, ding hf, sun w, huang zl, hu y.[clinical effect of nasal endoscope combined with supporting laryngoscope surgery in the treatment of polyps of vocal cord and its influence on voice function of patients].Lin chung er bi yan hou tou jing wai ke za zhi.2019 mar;33(3):272-274.Chinese.Doi: 10.13201/j.Issn.1001-1781.2019.03.021.Pmid: 30813701.

Event Description

It was reported that on literature review "clinical study of nasal endoscopy and microscopy of vocal cord masses with support laryngoscope", 13 patients had a postoperative soft palate abrasion and submucosal bruising of the posterior pharyngeal wall after procedure using a coblator ii surgery system.Unknown how the events were treated.Patients outcome are unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference (b)(4).H10 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.Insufficient product identification information was provided and thus a manufacturing record, complaint history, device labeling/instructions for use, risk management and capa, nc, pra/hhe 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.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 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.Should any additional relevant clinical information be provided, this case would be re-assessed.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: 13995594
• MDR Text Key: 288595771
• Report Number: 3006524618-2022-00165
• 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: 08/22/2022

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: UNKN04300102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• 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