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

Model Number	EICA8898-01
Health Effect - Clinical Codes	Feeding Problem (1850); Pain (1994); Sleep Dysfunction (2517)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 7 days after an adenoid procedure, a (b)(6) patient is experiencing pain.The patient is not sleeping, not eating, the throat is red and is taking pain medicines regularly.
Additional Manufacturer Narrative
The 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 since the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event is patient's general health, following post-operative instructions, or the presence of coexisting medical problems.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.Finally, the reported symptoms (worsening pain and refusal to drink/eat) may be surgical complications or related to the primary cause of the need for the adenoidectomy procedure itself; however, the root causes cannot be determined based on the information provided.The patient impact beyond the reported symptoms and likely dehydration cannot be determined as no additional interventions were reported.

• Brand Name: PROCISE MAX COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7564354
• Report Number: 3006524618-2018-00296
• Device Sequence Number: 11144032
• Product Code: GEI
• UDI-Device Identifier: 00817470003888
• UDI-Public: (01)00817470003888(17)210103(10)2009053
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: EICA8898-01
• Device Catalogue Number: EICA8898-01
• Device Lot Number: 2009053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 MO