MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT SUPER TURBOVAC 90 IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number ASHA4250-01

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2017

Event Type  malfunction  

Event Description

It was reported that the plate came off the tip of ambient super turbovac 90 during surgery.There is no evidence the plate was retrieved, but a thorough exploration of the shoulder joint and on-table x-ray were conducted and the plate could not be found.It could have been suctioned out using the mechanical shaver.No other complications were reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since 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, nor could a root cause be determined with confidence.Factors not associated with the manufacture or design of the device which could result in damage to the tip could be the device coming into abrupt contact with a hard (metallic) object, improper insertion or removal from an apparatus, use at a higher than recommended set point or excessive force applied to the tip can also lead to unintended detachment.

• Brand Name: AMBIENT SUPER TURBOVAC 90 IFS
• 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: jim gonzales ; 7000 w. william cannon; austin, TX 78735
• MDR Report Key: 6854270
• MDR Text Key: 85767034
• Report Number: 3006524618-2017-00255
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASHA4250-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2017
• 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