MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MEE-2000A; EVOKED RESPONSE ELECTRIC STIMULATOR

Model Number	MEE-2000A-LT
Medical Device Problem Codes	Failure to Deliver Energy (1211); Energy Output Problem (1431); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The surgical nurse reported that a patient was undergoing a spinal cord stimulator placement procedure and when the surgical nurse began monitoring the patients somatosensory evoked potential (ssep's) for detection of spinal cord injury or tetralogy of fallout (tof) cardiac anomaly's there was an error code that read, "electrical stimulator turned off because of error".Restart the electrical stimulator"?.The surgical nurse proceeded to restart the electrical stimulator and still could not monitor the patient.The surgical nurse reported that they unplugged/plugged the stim cable from the stim pod as well as the main unit.After doing this, the device showed error codes that said "you cannot restart the automatic trend sequence, because electric a1-a4 are not connected.Please check the stimulator is connected to the connector on the right side of the main unit".The surgical nurse noted that the light on the stim pod was not on.The surgeon was aware that the surgical nurse was having technical issues during the procedure.The surgical nurse stated that since the procedure was so quick, they were not able to get spare equipment in time, so they were unable to monitor the somatosensory evoked potential (ssep's) for detection of spinal cord injury or tetralogy of fallot (tof) cardiac anomaly for the case.The patient was unharmed.The surgical nurse reported that after the case was over they got another stim cable from a spare unit and tried it with the same stim pod and it was working fine, this confirmed to the surgical nurse that it was the stim cable that was not working properly and will be sending it into nihon kohden.
Additional Manufacturer Narrative
The surgical nurse reported that a patient was undergoing a spinal cord stimulator placement procedure and when the surgical nurse began monitoring the patients somatosensory evoked potential (ssep's) for detection of spinal cord injury or tetralogy of fallout (tof) cardiac anomaly's there was an error code that read, "electrical stimulator turned off because of error".Restart the electrical stimulator"?.The surgical nurse proceeded to restart the electrical stimulator and still could not monitor the patient.The surgical nurse reported that they unplugged/plugged the stim cable from the stim pod as well as the main unit.After doing this, the device showed error codes that said "you cannot restart the automatic trend sequence, because electric a1-a4 are not connected.Please check the stimulator is connected to the connector on the right side of the main unit".The surgical nurse noted that the light on the stim pod was not on.The surgeon was aware that the surgical nurse was having technical issues during the procedure.The surgical nurse stated that since the procedure was so quick, they were not able to get spare equipment in time, so they were unable to monitor the somatosensory evoked potential (ssep's) for detection of spinal cord injury or tetralogy of fallot (tof) cardiac anomaly for the case.The patient was unharmed.The surgical nurse reported that after the case was over they got another stim cable from a spare unit and tried it with the same stim pod and it was working fine, this confirmed to the surgical nurse that it was the stim cable that was not working properly and will be sending it into nihon kohden.The device that this complaint is for is the (b)(4) sn (b)(6) which is the stimulator cable used with the main unit mee-000a sn (b)(6).Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the mee-2000a: stim cable: model #: js-201b serial (b)(6) device manufacturer data: 02/24/2022 unique identifier (b)(4).
Additional Manufacturer Narrative
Incident summary: the surgical nurse reported that a patient was undergoing a spinal cord stimulator placement procedure and when the surgical nurse began monitoring the patients somatosensory evoked potential (ssep's) for detection of spinal cord injury or tetralogy of fallout (tof) cardiac anomaly's there was an error code that read, "electrical stimulator turned off because of error".Restart the electrical stimulator"?.The surgical nurse proceeded to restart the electrical stimulator and still could not monitor the patient.The surgical nurse reported that they unplugged/plugged the stim cable from the stim pod as well as the main unit.After doing this, the device showed error codes that said "you cannot restart the automatic trend sequence, because electric a1-a4 are not connected.Please check the stimulator is connected to the connector on the right side of the main unit".The surgical nurse noted that the light on the stim pod was not on.The surgeon was aware that the surgical nurse was having technical issues during the procedure.The surgical nurse stated that since the procedure was so quick, they were not able to get spare equipment in time, so they were unable to monitor the somatosensory evoked potential (ssep's) for detection of spinal cord injury or tetralogy of fallot (tof) cardiac anomaly for the case.The patient was unharmed.The surgical nurse reported that after the case was over they got another stim cable from a spare unit and tried it with the same stim pod and it was working fine, this confirmed to the surgical nurse that it was the stim cable that was not working properly and will be sending it into nihon kohden.The device that this complaint is for is the js-201b sn 821 which is the stimulator cable used with the main unit mee-000a sn 00323 troubleshooting measures: tech support (ts) responded to the customer's email and stated no cables were in stock and there was no time frame of when the cables would be restocked.Instead, ts sent the customer a replacement unit and recommended sending the cable and unit in for evaluation.The unit had a standard warranty from 01/12/2023 to 01/12/2024, making the device age approximately one year old.Evaluation/summary: on 03/01/2024, the unit and the cable were cleaned and decontaminated.The model, serial numbers, and labels were verified.Our repair technician tested the unit with the cable and discovered it failed.Afterwards, they tested the unit with a known working cable and the result was successful.Our repair technician also performed additional checks per service manual such as verifying the constant current output intensity with stim settings at 100 ma, 1 ms, and 5 hz.The waveform on the oscilloscope was verified.Overall, our repair technician concluded the cable was defective but confirmed the unit was functioning properly.They recommended the cable be scrapped.Root cause analysis: typically, damage to cables, inputs, outputs, and connectors may occur when excessive force is exerted or when the cable comes into repeated contact with surface or objects.Although there was patient involvement, there was no injury, no harm, nor any adverse event, due to the reported issue.Nihon kohden continues to monitor trends for this type of issue.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 - b7 attempt # 1: 01/17/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/25/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received and the surgical nurse provided more information of the event but did not provide the patient demographic information.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the mee-2000a: stim cable: model #: js-201b serial #: 821 device manufacturer data: 02/24/2022 unique identifier (udi) #: 04931921118085 additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type?.
Event or Problem Description
The surgical nurse reported that a patient was undergoing a spinal cord stimulator placement procedure and when the surgical nurse began monitoring the patients somatosensory evoked potential (ssep's) for detection of spinal cord injury or tetralogy of fallout (tof) cardiac anomaly's there was an error code that read, "electrical stimulator turned off because of error".Restart the electrical stimulator"?.The surgical nurse proceeded to restart the electrical stimulator and still could not monitor the patient.The surgical nurse reported that they unplugged/plugged the stim cable from the stim pod as well as the main unit.After doing this, the device showed error codes that said "you cannot restart the automatic trend sequence, because electric a1-a4 are not connected.Please check the stimulator is connected to the connector on the right side of the main unit".The surgical nurse noted that the light on the stim pod was not on.The surgeon was aware that the surgical nurse was having technical issues during the procedure.The surgical nurse stated that since the procedure was so quick, they were not able to get spare equipment in time, so they were unable to monitor the somatosensory evoked potential (ssep's) for detection of spinal cord injury or tetralogy of fallot (tof) cardiac anomaly for the case.The patient was unharmed.The surgical nurse reported that after the case was over they got another stim cable from a spare unit and tried it with the same stim pod and it was working fine, this confirmed to the surgical nurse that it was the stim cable that was not working properly and will be sending it into nihon kohden.

• Brand Name: MEE-2000A
• Common Device Name: EVOKED RESPONSE ELECTRIC STIMULATOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18663606
• Report Number: 8030229-2024-04124
• Device Sequence Number: 8001932
• Product Code: GWF
• UDI-Device Identifier: 00841983103629
• UDI-Public: 00841983103629
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: MEE-2000A-LT
• Device Catalogue Number: MEE-2000A-LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JS-201B (B)(6); JS-201B (B)(6)
• Patient Sex: Unknown