MAUDE Adverse Event Report: ARTHROCARE CORP. REFLEX ULTRA 45 COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EIC4845-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the front part of the wand was a bit broken.It is unknown if a delay happened, when the issue was discovered and if a backup device was available.However, no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Complaint internal reference: (b)(4).H10, h2, h3, h6: the reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number 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 isolated event.Visual evaluation shows minimal electrode erosion, chipped spacer, and scratched return shaft.The wand was connected to a compatible c2 controller and activated in saline solution at default and max settings and on ablate- and coagulation and produced plasma on the electrodes as intended; however, arcing was observed due to the cracked spacer.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) incorrect power cycling of the controller (3) mechanical displacement of tissue through applied force (3) usage of the wand as a lever to enlarge a surgical site or gain access to tissue as this may result in a bent or damage to device leading to patient injury (4) damage includes bending or detachment of the distal end of the device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: REFLEX ULTRA 45 COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10797175
• Report Number: 3006524618-2020-00954
• Device Sequence Number: 11481906
• Product Code: GEI
• UDI-Device Identifier: 00817470004212
• UDI-Public: 00817470004212
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 02/14/2023
• Device Model Number: EIC4845-01
• Device Catalogue Number: EIC4845-01
• Device Lot Number: 2050321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1