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

Model Number	EIC7071-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that during a laryngeal procedure, the procise wand stopped working intra-operatively.It was not reported if there were any delays in a surgical procedure.The procedure was completed using a regular cautery.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 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.A review of the device history records for the device 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 isolate issue.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (1) rate of ablation (2) power settings (3) an issue with one of the concomitant devices in use at the time of this complaint event.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 11036933
• Report Number: 3006524618-2020-01104
• Device Sequence Number: 1193543
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2021
• Device Model Number: EIC7071-01
• Device Catalogue Number: EIC7071-01
• Device Lot Number: 2023362
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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: Required Intervention