MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS CURVED SHARP RF CANNULA, RADIOPAQUE MARKER; STANDARD RF PROBES AND CANNULAS

Model Number	PMF20-100-10CS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is in-progress.The actual complaint product was returned for evaluation.The investigation remains in progress.All information reasonably known as of 17 sep 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the radiopaque collar on the standard radiofrequency probe cannula was retained in the patient.Additional information received 27-aug-2021 indicated the retained component was the "'collar' of the cannula at the distal most margin of the shielded black component of the cannula where the shielded portion meets the unshielded portion." procedure was "bilateral lumbar l3, l4 and l5 medial branch radiofrequency ablation." the probe collar is located adjacent to the right l5 superior articular process.A ct lumbar spine was performed.Neurosurgical consultation was performed without any further intervention recommended.No apparent patient adverse effects.
Additional Manufacturer Narrative
The device history record for the reported lot number, 301277052, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One (1) cannula with the molded stylet inside the cannula was received.An original pouch packaging was also returned and it was opened.No other components were received.The sample was visually inspected in an ambient light conditions with the unaided eye after cleaning and disinfection.The device was evaluated, when looking at the tip portion of the tubing, it was smooth and undamaged.The root cause was traced to manufacturing process.Actions are being taken in process to avoid recurrence of this issue.All information reasonably known as of 22-nov-2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint comp-(b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: AVANOS CURVED SHARP RF CANNULA, RADIOPAQUE MARKER
• Common Device Name: STANDARD RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12494737
• Report Number: 8030647-2021-00038
• Device Sequence Number: 5173530
• Product Code: GXI
• UDI-Device Identifier: 00193493986347
• UDI-Public: 00193493986347
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K972846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 03/24/2025
• Device Model Number: PMF20-100-10CS
• Device Catalogue Number: N/A
• Device Lot Number: 30127052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 100 KG