MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-02-17 for NEZHAT DORSEY TUBE SET * 5102720 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[378494]
Suction button stuck in open position one hour into total heystrectomy. Loss of pneumo. No robotocs. Four previous incidents not reported. Customer declined to answer any further questions. No smokevac involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2005-00022 |
| MDR Report Key | 578542 |
| Report Source | 06 |
| Date Received | 2005-02-17 |
| Date of Report | 2005-01-18 |
| Date of Event | 2005-01-18 |
| Date Mfgr Received | 2005-01-18 |
| Date Added to Maude | 2005-03-08 |
| 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 | THOMAS SWANSON |
| Manufacturer Street | 100 SOCKANOSSETT CROSSROAD |
| Manufacturer City | CRANSTON RI 02920 |
| Manufacturer Country | US |
| Manufacturer Postal | 02920 |
| Manufacturer Phone | 4014637000 |
| Manufacturer G1 | DAVOL SURGICAL INNOVATIONS |
| Manufacturer Street | AVE. ROBERTO FIERRO #6408 PARQUE INDUSTRIAL AEROPUERTO |
| Manufacturer City | CD.JUAREZ, CHIH S.A. DE C.V. 32690 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEZHAT DORSEY TUBE SET |
| Generic Name | LAPAROSCOPIC TUBE SET |
| Product Code | GGJ |
| Date Received | 2005-02-17 |
| Model Number | * |
| Catalog Number | 5102720 |
| Lot Number | 41KON011 |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 568392 |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Manufacturer Address | * CRANSTON RI * US |
| Baseline Brand Name | NEZHAT DORSEY TUBE SET |
| Baseline Generic Name | LAPAROSCOPIC TUBE SET |
| Baseline Catalog No | 5102720 |
| Baseline Device Family | NEZHAT DORSEY TUBE SET |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K913944 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-17 |