MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for RUSCH EZ-BLOCKER KIT MG-02770-002 manufactured by Teleflex Incorporated.
[174296014]
During a right video-assisted thoracoscopic surgery (vats) and lower lobectomy, patient was in lateral position for right side exposure. Anesthesia had been asked to use a lung blocker or isolation device to prevent ventilation of the lung the surgeon was wanting to operate on. Anesthesia successfully placed the device. However, the device failed to prevent the patient's lung from inflating. The balloon sheared off from the tubing and as a result, the balloon would not stay inflated, to prevent the lung from filling. The surgeon was forced to stop the procedure, while anesthesia did troubleshooting of the situation. It was determined by anesthesia that it would be best to use a new device. The new device worked as expected. The device was a: rusch ez-blocker kit accessory. Ref: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9568668 |
| MDR Report Key | 9568668 |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-21 |
| Date of Event | 2019-11-12 |
| Report Date | 2019-12-21 |
| Date Reported to FDA | 2019-12-21 |
| Date Reported to Mfgr | 2020-01-09 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH EZ-BLOCKER KIT |
| Generic Name | TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) |
| Product Code | CBI |
| Date Received | 2020-01-09 |
| Catalog Number | MG-02770-002 |
| Lot Number | 71F19E2195 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX INCORPORATED |
| Manufacturer Address | PO BOX 12600 DURHAM NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |