MAUDE Adverse Event Report: AVANOS MEDICAL INC. NITINOL RF PROBE, STRAIGHT-100; STANDARD RF PROBES AND CANNULAS

Model Number	PMP-100-N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced an infected wound requiring a skin graft, the plastic surgeon had to perform a skin graft.Patient status listed as recovering.The patient underwent a genicular nerve rf [radio frequency] ablation.The inferior medial lesion (over the medial border of the upper tibia) showed erratic temperature and power readings.The lesion was stopped and restarted several times with the same outcome.The procedure was then abandoned.There was some increased swelling noted at the time of the lesion.The patient had an unusual amount of post procedure pain.The patient was contacted via telephone and only complained of pain.The wound started to breakdown at the procedure site after a week and developed a large cavity by the second week.The procedure site had become infected.The patient was referred to a plastic surgeon for further management of the wound.The generator activation only lasted a maximum of 30 seconds before giving an error message, the procedure was performed using a 100mm nimbus needle.Additional information received 04-nov-2022 stating the physician was using the nimbus needle instead of the avanos rf cannula (larger lesion preference).The patient did not suffer from any other significant medical problems.
Additional Manufacturer Narrative
The device history record for the reported lot number, m19059k503, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample is reported to be available but has not yet been received by the manufacturer.All information reasonably known as of 14-nov-2022 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).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.The device was not returned.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 21-dec-2022 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).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.
Additional Manufacturer Narrative
The probe was received without the product package or label.The device was evaluated.The device passed the functional evaluation testing.A root cause was not identified.All information reasonably known as of 18-jan-2023 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).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: NITINOL RF PROBE, STRAIGHT-100
• 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: 15793014
• Report Number: 8030647-2022-00214
• Device Sequence Number: 14218717
• Product Code: GXI
• UDI-Device Identifier: 00193493303939
• UDI-Public: 00193493303939
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2023

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 Model Number: PMP-100-N
• Device Catalogue Number: N/A
• Device Lot Number: M19059K503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 12/21/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/22/2022; 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Male