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

Catalog Number	AC4330-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a hip arthroscopy, the piece bent in the joint and at the time of fixing it broke.The event occurred outside the patient.The procedure was completed without significant delay using a competitor back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was a relationship between the subject device and the reported event.Visual inspection of the device found that the tungsten hook was completely destroyed, and the spacer of the device experienced discoloration.The wand was connected to a known good controller, which revealed that despite the tungsten hook being destroyed, the device was able to activate in coagulate and ablate modes.The complaint was verified, but the root cause could not be determined with confidence.Factors, which could have contributed to the reported event includes: 1.Prior to initial use, ensure that all package inserts, including warnings, precautions, user¿s manual, and instructions for use are read and understood.2.Safe and effective electrosurgery is dependent not only on equipment design, but also, to a large extent, on factors under the user¿s control.3.This wand is designed for ablation and/or coagulation only, and not for mechanical displacement of tissue through applied force.This may result in bent or detached electrodes, damage to device and/or cracked spacer.4.Do not use the wand as a lever to enlarge surgical site or gain access to tissue, which may result in bent or detached electrodes, damage to device and/or cracked spacer.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: SABER 30 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9109442
• Report Number: 3006524618-2019-00483
• Device Sequence Number: 3762641
• Product Code: GEI
• UDI-Device Identifier: 00817470004854
• UDI-Public: 00817470004854
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: AC4330-01
• Device Lot Number: 1195071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 08/31/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR