MAUDE Adverse Event Report: ARTHROCARE CORP. SABER 30 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number AC4330-01

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/24/2020

Event Type  Injury  

Event Description

It was reported that during an arthroscopy, the tip of the saber coblation wand broke off when it was being used to incise the hip capsule and access to the joint.The broken tip could not be removed from the patient.The procedure was successfully completed without 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.

Manufacturer Narrative

H10: h2, h6.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.Clinical evaluation was completed and concluded that based on the limited information provided the root cause of the reported wand tip breakage could not be determined.The device instructions for use does caution to ¿check the electrodes intermittingly to ensure they are intact.¿ although the cytotoxicity results report that the device passed cytotoxicity testing and is considered non-toxic, this is for short term use.Long term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and probable mri restrictions cannot be determined.No further medical assessment can be rendered at this time.A review of the instructions for use found that excessive applied force can result in device failure.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) insufficient suction flow causing the wand to overheat and degenerate at a faster rate.(2) hitting the tip against a hard surface such as a metal or bone (3) extensive use of the wand causing excessive screen/ electrode erosion (4) operating the wand at a different setting than recommended by the instructions for use.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

H10 h3,h6: 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 portion of the tip and electrode are detached.The device was plugged into the controller and registered settings (1,7).The wand was able to generate plasma as intended.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.Clinical evaluation was completed and concluded that based on the limited information provided the root cause of the reported wand tip breakage could not be determined.The device ifu does caution to ¿check the electrodes intermittingly to ensure they are intact.¿ although the cytotoxicity results report that the device passed cytotoxicity testing and is considered non-toxic, this is for short term use.Long term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and probable mri restrictions cannot be determined.No further medical assessment can be rendered at this time.A review of the instructions for use found that excessive applied force can result in device failure.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) insufficient suction flow causing the wand to overheat and degenerate at a faster rate.(2) hitting the tip against a hard surface such as a metal or bone (3) extensive use of the wand causing excessive screen/ electrode erosion (4) operating the wand at a different setting than recommended by the ifu.

• Brand Name: SABER 30 DEGREE ICW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10853327
• MDR Text Key: 216671880
• Report Number: 3006524618-2020-01002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470004854
• UDI-Public: 00817470004854
• Combination Product (y/n): N
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: AC4330-01
• Device Catalogue Number: AC4330-01
• Device Lot Number: 2043008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR