MAUDE Adverse Event Report: ARTHROCARE CORP. FLOW 50; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number FSHA6050-01

Device Problems Component Falling (1105); Loose or Intermittent Connection (1371); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/29/2017

Event Type  malfunction  

Event Description

A metal piece from a flow 50 wand was loosened during an arthroscopic hip surgery, fell of and was remained in the patient because it could not be found.The event occured immediately when the surgeon brought the wand in through a portal.The procedure was completed using a backup device.

Manufacturer Narrative

The complaint has been visually verified and the root cause was more than likely associated with the device potentially coming into contact with the boundaries of a metal object such as a cannula.Other potential factors which could have contributed to the reported event includes: mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue.The instruction for use (¿ifu¿) outlines warnings and precautionary measures to adhere to during activation of the device.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FLOW 50
• 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 dr.; austin, TX 78735
• MDR Report Key: 6650170
• MDR Text Key: 77943137
• Report Number: 3006524618-2017-00147
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K143235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FSHA6050-01
• Device Lot Number: 1153213
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1