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

Catalog Number FSHA6050-01

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/12/2018

Event Type  malfunction  

Event Description

It was reported that the metal tip on the end of the wand came off mid-operation and got lost inside the patient.Therefore we could not use it and had to open another one.The surgeon wasn't able to retrieve the metal tip so it is still inside the patient.There was a surgical delay greater than 30 minutes.

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 customer's complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Factors that could have led to tip detachment includes: using the device against a bony, sharp, or otherwise hard surface, improper insertion or removal from an apparatus as reported in the complaint, or excessive force applied to the tip can all lead to unintended detachment.There are no indications to suggest the wand did not meet product specifications upon release into distribution.

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 the electrodes have been detached with jagged edges on the remaining electrode legs.There are scuff marks present on the spacer.There are no manufacturing abnormalities visually observed with the returned wand.The wand was connected to a compatible werewolf controller and was activated in saline solution at the default and max settings on the controller and plasma was observed on the remaining electrode legs.Factors that could have led to tip detachment includes: using the device against a bony, sharp, or otherwise hard surface, improper insertion or removal from an apparatus as reported in the complaint, or excessive force applied to the tip can all lead to unintended detachment.

• Brand Name: FLOW 50
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7607962
• MDR Text Key: 111849318
• Report Number: 3006524618-2018-00321
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K143235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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: 1162757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR