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

Catalog Number	EIC7071-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an unspecified surgery, when the wand was opened and being primed with 0.9% nacl, the irrigation tubing was leaking, as this had a pinprick hole.A back-up device was available to complete the procedure.The surgery was delayed for more than half-an-hour.The patient was not injured.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.Visual inspection under magnification shows minimal electrode wear with dried tissue and discoloration present on the tip.The saline line has been ripped due to separation from the suction line.There is a small hole in the saline tubing.There are no manufacturing abnormalities observed with the returned device.The wand was connected to a compatible controller and activated in saline solution using default and max settings and the ablate and coag performed as intended.The suction line was tested and performed as intended.Due to a rip in the saline line, saline leaked out from the line preventing sufficient saline flow to the tip; therefore, the saline line did not perform as intended.The complaint has been confirmed; however, evidence would suggest customer modification.It is possible that an attempted was made to separate the suction and saline lines and in doing so the saline line was inadvertently ripped.There are no indications during manufacturing record review that would suggest the wand did not meet product specifications upon release into distribution.

• Brand Name: PROCISE MINI LARYNGEAL COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8774292
• Report Number: 3006524618-2019-00324
• Device Sequence Number: 11231961
• Product Code: GEI
• UDI-Device Identifier: 00817470000597
• UDI-Public: 00817470000597
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070374
• 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): 08/07/2019

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: 11/16/2021
• Device Catalogue Number: EIC7071-01
• Device Lot Number: 2023362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1