MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-30 for ILLUMISITE ILS-1000-CS manufactured by Covidien Lp - Superdimension Inc.
[177028364]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177028365]
According to the reporter during a procedure, the system kept flickering and was saying that the locatable guide decoupled and would not recognized the locatable guide and extended working channel, they tried a new kit however the same result occurred. It would say decoupled and when going to the lower lobes the error would be removed. They pulled back to the main carina and the issue came back. A 3rd kit was tried and the same issue occurred. It would appear normal with the locatable guide in the extended working channel position. The device eventually shut off. The patient was under conscious sedation. The physician was not able to complete the superdimension portion of the case nor was the case completed by other means.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2020-00008 |
| MDR Report Key | 9648936 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-10-21 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILLUMISITE |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2020-01-30 |
| Model Number | ILS-1000-CS |
| Catalog Number | ILS-1000-CS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Address | 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |