MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-12-13 for 215532 manufactured by Rusch, Inc..
[214004]
On unknown date during a long limb gastric bypass surgery on a morbidly obese individual the surgeon of record asked the anesthetist to pass a bougie dilator down the esophagus. The device was a blue # 32 rusch inc. , hurst bougie dilator. Inadvertently, while watching and discussing with the surgeon, the anesthetist inserted the bougie backwards (blunt end first) into the esophagus causing a "tear from the ge junction extending 3 cms into the posterior cardia. " this tear was repaired intraoperatively and it appears the pt suffered no long term sequelae. In a systems review, it was noted that both blunt and tapered ends of the bougie were quite similar in diameter and either end of the device could easily pass down the esophagus. Co's hope is that the mfr might design a device with a handle on one end making it impossible to pass it improperly or that both ends of the device be tapered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-2000-00111 |
| MDR Report Key | 308863 |
| Report Source | 00 |
| Date Received | 2000-12-13 |
| Date of Report | 2000-12-13 |
| Date of Event | 2000-08-16 |
| Date Mfgr Received | 2000-12-11 |
| Date Added to Maude | 2000-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM SLEVIN, MANAGER |
| Manufacturer Street | 2450 MEADOWBROOK PKWY |
| Manufacturer City | DULUTH GA 30096 |
| Manufacturer Country | US |
| Manufacturer Postal | 30096 |
| Manufacturer Phone | 7706230816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FAT |
| Date Received | 2000-12-13 |
| Model Number | NA |
| Catalog Number | 215532 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 290468 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY DULUTH GA 30096 US |
| Baseline Brand Name | RUSCH, INC. HURST BOUGIE DILATOR |
| Baseline Generic Name | #32 BOUGIE DILATOR |
| Baseline Model No | NA |
| Baseline Catalog No | 215532 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-12-13 |