MAUDE Adverse Event Report: COVIDIEN LLC NIM® PROBE; STIMULATOR, NERVE

Model Number	8225275
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during procedure after being connected, the probe did not react.The probe was switched out with backup product and the procedure was carried out normally.Device had contact with patient.There was no surgical delay.There was no patient impact reported.
Additional Manufacturer Narrative
H3 : analysis of product 8225275 of lot# 0222590809 found that there was a residue consistent with biological contaminants on the device.Visually, there was no external damage in the construction of the device that would have resulted in the reported event.There was biological contaminant on the handle.Electrically, the resistance of the entire assembly should be less than 0.3 ohms and the actual measurement was 0.3 ohms which was within specification.The probe tip fit securely into the handle with no issues.Functionally, the probe connected to a nim system using a 1.0 ma stimulating current and a 100 ¿v threshold and, while stimulating with a patient simulator, the system consistently returned 1.02 ma and a waveform/event tone over 200 ¿v.There was no intermittent behavior while manipulating the tip, connector, or the wire.A review of the global complaint data showed no similar complaints about this lot number.In the returned condition, there was no out of specification condition that was related to the complaint.H6 : codes updated and previous fdm b21, fdr c21 and fdc d16 codes no longer applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow-up it was reported that when probe touched the patient, no stimulation took place.There was no patient or staff impact.Stimulus set to 1.0 ma and threshold set to 100 microv.Stim return, located under the stimulus setting on the monitor, show 0, which indicate that no current was being delivered.With the replacement probe, the surgery was carried out in a normal fashion without mentionable events.A nim tube was used during the procedure.No details on the type and/or lot number of the tube and not relevant to stimulation.There was no malfunction with the nim tube.

• Brand Name: NIM® PROBE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 14792196
• Report Number: 9612501-2022-01011
• Device Sequence Number: 11995225
• Product Code: ETN
• UDI-Device Identifier: 00763000036096
• UDI-Public: 00763000036096
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K934426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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 Model Number: 8225275
• Device Catalogue Number: 8225275
• Device Lot Number: 0222590809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown