MAUDE Adverse Event Report: SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC) SENTIO SENSOR 8 PK W GROUND; NEUROSURGICAL NERVE LOCATOR

Catalog Number 286202008

Device Problem Device Alarm System (1012)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2019, the unknown electrodes were placed once the patient was asleep with the authorization of the doctor, each of which is in the corresponding place for cervical surgery.The surgery started, as it continued to progress it began to create red alerts as if a patch was disconnected.The electrodes where checked and the equipment patch six (6) was observed to have a problem but without finding anything wrong with it and so an alert was not issued and proceed with changing the patch.It was then realized that the corresponding area of the patient had a third (3rd) degree burn.So the doctor requested preventive measures to ensure the health of the patient.The patch was not put back while they were finishing the procedure.It was made mention that the sentio unit was alerting a problem with the sensor and the operating room staff ignored the alerts initially.The patient has been seen post-op a few times and was in the process of healing.The procedure outcome was unknown.This complaint involves one (1) device.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: SENTIO SENSOR 8 PK W GROUND
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8718251
• MDR Text Key: 148656460
• Report Number: 1526439-2019-51774
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Public: (01)UNAVAILABLE
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K131304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 286202008
• Device Lot Number: 210053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 07/02/2019; 08/29/2019
• Supplement Dates FDA Received: 07/23/2019; 08/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1