MAUDE Adverse Event Report: ARTHROCARE CORP. EVAC 70 XTRA COBLATOR II; 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 05/01/2010

Event Type  Injury  

Event Description

It was reported that on literature review "a preliminary study of the secondary postoperative haemorrhage in pediatric coblation adenotonsillectomy", 7 patients returned to the hospital for observation after a coblation adenotonsillectomy procedure using a evac 70 coblation wand.The patients required an anti-infection treatment.Patients outcome is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Paper: a preliminary study of the secondary postoperative haemorrhage in pediatric coblation adenotonsillectomy.Doi: 10.3760/cma.J.Issn1673-860.2010.05.006.

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 review, complaint history review, the instructions for use, risk management review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A clinical review states that the fully translated journal article was provided and has been reviewed.Reportedly, the patients required anti-infective treatment.Based on the information provided, 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, as it has been communicated, no additional information is available.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.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.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.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.H11: h2: correction on h6 (health effect - impact code).

• Brand Name: EVAC 70 XTRA COBLATOR II
• 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: 15505968
• MDR Text Key: 300817601
• Report Number: 3006524618-2022-00419
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/10/2023
• 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