MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-10 for PILLING INC. HURST BOUGIE DILATOR 507601 215532 manufactured by Pilling Surgical.
[169782]
During long limb gastric bypass surgery on a morbidly obese pt 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 gastro-esophageal 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. It is rptr's hope 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 | MW1020134 |
| MDR Report Key | 300093 |
| Date Received | 2000-10-10 |
| Date of Event | 2000-08-16 |
| Date Added to Maude | 2000-10-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING INC. HURST BOUGIE DILATOR |
| Generic Name | #32 BOUGIE DILATOR |
| Product Code | FAT |
| Date Received | 2000-10-10 |
| Model Number | 507601 |
| Catalog Number | 215532 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 290468 |
| Manufacturer | PILLING SURGICAL |
| Manufacturer Address | 420 DELAWARE DRIVE FORT WASHINGTON PA 19034 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 | 1. Required No Informationntervention | 2000-10-10 |