MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC ILLUMISITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number ILS-1000-CS

Device Problems Break (1069); Application Program Problem (2880); Device Sensing Problem (2917)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2022

Event Type  Injury  

Manufacturer Narrative

Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter during the procedure, the patient sensor triplet (pst) was not showing on the system and saw a damaged cable.It was also noted that the location board (lb) connecting cable looked very worn.Sending overnight a new pst, lb cables.The patient was under anesthesia.The physician was not able to complete the case, and was not completed by other means.

• Brand Name: ILLUMISITE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 14206281
• MDR Text Key: 290055836
• Report Number: 3004962788-2022-00029
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521723634
• UDI-Public: 10884521723634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ILS-1000-CS
• Device Catalogue Number: ILS-1000-CS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2022
• Date Device Manufactured: 10/19/2020
• 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
• Patient Outcome(s): Other