MAUDE Adverse Event Report: ARTHROCARE CORP. TURBOVAC 90 XL ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASC1336-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during surgery when the starvac coblation wand was used, there was no problem at the beginning, but when it was used continuously, the doctor realized through the screen that the body of the wand was peeled; he noticed that a coating was missing in the body of the product, likewise, he noticed that there were not 4 pin in the head of the tip he just found 2 pins and they did not heat up (plasma layer).He passed another unit (same reference) and the procedure was completed.The product was opened inside the operating room and it was given to the instrumentalist to reach it to the doctor, there was no other person to manipulate the product.No patient injury was reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows significant damage to the tip.The bottom electrodes have been detached with jagged edges and the left side of the spacer has been chipped.There are numerous scratch marks present on the spacer and the shaft.There are no manufacturing abnormalities visually observed with the returned device.The wand was connected to a compatible controller and activated in saline solution at the default and max settings on the controller and despite detachment of the bottom electrodes; plasma was created on the remaining electrodes.The suction line was tested and performed as intended.The complaint was verified and the root cause could not be determined as there are several factors that could cause this type of failure such as: ensure that the tip does not come into contact with another apparatus such as a cannula which could cause the electrodes to detach and spacer to become chipped, ensure that the default set point is being used.Higher settings may reduce life expectancy of the device and cause the electrode to detach, or excessive force applied to the tip can also lead to unintended detachment.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.We cannot determine if there is a relationship between the device and the incident because the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.Based on the photos supplied, there are several factors that could cause this type of failure such as: (1) ensure that the tip does not come into contact with another apparatus such as a cannula which could cause the electrode to detach and spacer to become chipped as can be seen in the photos, (2) ensure that the default set point is being used.Higher settings may reduce life expectancy of the device and cause the electrode to detach, or (3) excessive force applied to the tip can also lead to unintended detachment and are outlined in the precautionary statements in the instruction for use (¿ifu¿).There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TURBOVAC 90 XL ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7065552
• Report Number: 3006524618-2017-00377
• Device Sequence Number: 13484356
• Product Code: GEI
• UDI-Device Identifier: 00817470006520
• UDI-Public: (01)00817470006520(17)190831(10)1160697
• Combination Product (Y/N): N
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: ASC1336-01
• Device Catalogue Number: ASC1336-01
• Device Lot Number: 1160697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 01/24/2018; 08/04/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 01/29/2018; 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 45