MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-08-23 for ARNDT ENDOBRONCHIAL BLOCKER SET N/A C-AEBS-7.0-65-SPH-AS manufactured by Cook Inc.
[175686511]
(b)(6). Occupation: manager. Pma/510(k) #: k021920. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[175686512]
It was reported that an arndt endobronchial blocker set was used for practice procedures on pigs in a wetlab of intuitive surgical korea. During the procedure, it was noticed that the shape of the balloon on the blocker catheter was not spherical, and that it was irregular as compared to the common blocker balloon shape. This product was only used for practice procedures on pigs, and made no human contact. No other adverse effects were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02101 |
| MDR Report Key | 8925760 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-08-23 |
| Date of Report | 2019-09-13 |
| Date of Event | 2019-08-12 |
| Date Mfgr Received | 2019-09-10 |
| Date Added to Maude | 2019-08-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARNDT ENDOBRONCHIAL BLOCKER SET |
| Generic Name | CBI TUBE, TRACHEAL/BRONCHIAL |
| Product Code | CBI |
| Date Received | 2019-08-23 |
| Returned To Mfg | 2019-08-23 |
| Model Number | N/A |
| Catalog Number | C-AEBS-7.0-65-SPH-AS |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-23 |