MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1999-04-19 for RSP ESOPHAGEAL STETHOSCOPE, 18FR VES400-18 manufactured by Sims/respiratory Support Products.
[17487676]
Reportedly, a 66 yr old male pt (weight approx 220 lbs) developed an esophageal rupture 3 days after undergoing a radical prostatectomy, the rupture was discovered on an x-ray 3 days after surgery when the pt developed severe shortness of breath and his "o2 saturation had dropped". The rupture was thoracically repaired. When questioned as to whether or not the pt may have had a weakness in the esophagus prior to the esophageal stethoscope being used, the certified registered nurse anesthetist stated, "during the thoracic surgery to repair the rupture, it was observed that the pt had an inflamed esophagus and a hiatal hernia. " the rupture was in an up and down configuration (not across the esophagus). The size of the rupture is unreported. The pt recovered nicely and was released from the hosp. The certified registered nurse anesthetist stated the origin of the esophageal rupture is unk. The esophageal stethoscope was discarded after the first surgery. The lot number is unreported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020364-1999-00002 |
| MDR Report Key | 220837 |
| Report Source | 05,07 |
| Date Received | 1999-04-19 |
| Date of Report | 1999-04-16 |
| Date of Event | 1999-02-23 |
| Date Facility Aware | 1999-02-23 |
| Report Date | 1999-04-16 |
| Date Mfgr Received | 1999-03-23 |
| Date Added to Maude | 1999-04-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RSP ESOPHAGEAL STETHOSCOPE, 18FR |
| Generic Name | ESOPHAGEAL STETHOSCOPE, 18FR |
| Product Code | BZW |
| Date Received | 1999-04-19 |
| Model Number | VES400-18 |
| Catalog Number | VES400-18 |
| Lot Number | UNREPORTED |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 214180 |
| Manufacturer | SIMS/RESPIRATORY SUPPORT PRODUCTS |
| Manufacturer Address | 2552 MCGAW AVE. IRVINE CA 92614 US |
| Baseline Brand Name | RSP ESOPHAGEAL STETHOSCOPE, 18FR |
| Baseline Generic Name | ESOPHAGEAL STETHOSCOPE, 18FR |
| Baseline Model No | VES400-18 |
| Baseline Catalog No | VES400-18 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-04-19 |