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 Problem Adhesion(s) (1695)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Article citation: zhu hengcai, cheng lei, shi xiangwei, li jiali, & shao zongzhi.(2014).Effect of adenoid hypertrophy on the outcome of treatment for sinusitis in children after melting.Chinese journal of integrated traditional and western medicine of otorhinolaryngology, 22(1), 43-46.

Event Description

It was reported that on literature review effect of adenoid hypertrophy and fusion resection on the outcome of children's sinusitis, 2 patients had an external migration of the middle turbinate with adhesions, the adhesions were separated in the outpatient clinic, and the patients and their families were satisfied.No further information is available.

Manufacturer Narrative

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 corrective and preventive actions, non conformance, probabilistic risk assessment/health hazard evaluation 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.Smith and nephew has not received the device and/or adequate documentation to fully evaluate the root cause of the reported event.Therefore, the root cause of the reported ¿2 patients had an external migration of the middle turbinate with adhesions¿ and/or the patient outcome beyond that which was documented in the aged article cannot be confirmed nor concluded.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; ausitn, TX 78735 ; 5123913905
• MDR Report Key: 13995111
• MDR Text Key: 288490103
• Report Number: 3006524618-2022-00168
• 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: 09/25/2022

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: 09/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention