MAUDE Adverse Event Report: ARTHROCARE CORP. PROCISE LW COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EICA7070-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the device broke, where the head is (the end of the tip).It is unknown if the broken pieces were removed from the patient.A backup device was available to complete the procedure with no delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The procise lw coblator ii wand, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.From the information provided, ¿during the surgery the device broke, where the head is (the end of the tip).Nothing was left in the patient.¿ visual inspection under magnification shows moderate electrode wear and the top portion of the electrode has been detached.There is dried tissue and discoloration present on the tip.There are no manufacturing abnormalities visually observed with the returned device.During functional evaluation the returned device was activated in saline solution using a good coblator ii controller.The device was tested in saline solution at coblate/coagulate mode in standard and maximum settings.Plasma was generated on the remaining electrode, and the device performed as intended.The complaint has been visually verified and the root cause could not be determined with confidence as a number of factors can lead to electrode damage.The wand tip may have come into contact with another metal object, mechanical displacement of tissue through applied force, using set points higher than the default settings or using the wand for an extended period of time.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.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: PROCISE LW COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9257896
• Report Number: 3006524618-2019-00531
• Device Sequence Number: 19470477
• Product Code: GEI
• UDI-Device Identifier: 00817470004243
• UDI-Public: 00817470004243
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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: 11/23/2021
• Device Catalogue Number: EICA7070-01
• Device Lot Number: 2024094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR