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

Model Number	8225275
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis found that visually, there was no damage in the construction of the device.The probe tip was inserted into the handle when returned and the packaging pouch was not returned.Electrically, resistance of the entire assembly shall be less than 0.3 ohms and the actual measurement was 0.3 ohms which was in specification.The tip fit securely into the handle with no issues.Functionally, the probe was connected to a nim system using a 1.0ma stimulating current and 100v threshold and, while stimulating with a patient simulator, the system consistently returned 1.0ma and a waveform/event tone over 200 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.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
It was reported that during the thyroidectomy procedure, when the doctor used the probe to detect the nerve, he found that the probe would reaction delay. the doctor tried to reconnect the probe but useless.The stim returned shows 3ma.There were no visual and/or audible indicators that alerted the user of the issue.No error codes are displayed.The issue was not resolved by repositioning or troubleshooting.Finally, the doctor changed a new probe to complete the surgery.There was no injury to the patient.

• 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: 18108245
• Report Number: 9612501-2023-01977
• Device Sequence Number: 20334419
• Product Code: ETN
• UDI-Device Identifier: 00763000036096
• UDI-Public: 00763000036096
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

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: 0225375209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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: Female