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

Model Number ASC4250-01

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, there was a piece of the electrode of the turbovac wand lost in the patient's hip joint.A dislocation of the hip was necessary to remove it.The procedure was successfully completed with a significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during a hip arthroscopy, there was a piece of the electrode of the turbovac wand lost in the patient's hip joint.A dislocation of the hip was necessary to remove it.The procedure was successfully completed with a significant delay using a back-up device.Due to the prolongation of the surgery, it caused paresthesia in the pelvis and stroke of foot.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported 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.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolate issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found adequate warnings and precautions to prevent damage to the device during use.As per clinical evaluation, s+n has not received the device and/or adequate documentation to fully evaluate the root cause of the reported events.The patient impact beyond the reported event could not be determined based on the limited information provided.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (1) the wand is designed for ablation and/or coagulation only, and not for mechanical displacement of tissue through applied force (2) do not use the wand as a lever to enlarge a surgical site or gain access to tissue as this may result in a bent or detached electrode, damage to device, and/or a cracked spacer leading to patient injury (3) the wand may have come into contact with a hard surface such as bone or another piece of equipment which could have caused damaged to the tip.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows the wand cable and suction tube have been cut and removed from wand.Portion of the electrode is detached.A functional evaluation could not be conducted due to tubing and wand cable being cut and removed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review for this lot concluded this was an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The patient impact beyond the reported event could not be determined based on the limited information provided.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.The complaint was confirmed.Factors that could have contributed to the reported event include:(1) hitting the device tip against a hard surface.(2) using the device as a lever to enlarge surgical site.(3) mechanical displacement of tissue through applied force.(4) activating the device above recommended settings for prolonged periods of time.No containment or corrective actions are recommended at this time.

• Brand Name: SUPER TURBOVAC 90 ICW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10871403
• MDR Text Key: 217288990
• Report Number: 3006524618-2020-01009
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470006421
• UDI-Public: 00817470006421
• Combination Product (y/n): N
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: ASC4250-01
• Device Catalogue Number: ASC4250-01
• Device Lot Number: 2053082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention