MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2009-12-28 for DEROYAL ESOPHAGEAL STETHOSCOPE 400 SERIES 81-040418 manufactured by Deroyal Industries, Inc..
[1309932]
The anesthesiologist noticed the patient's temperature dropping during a procedure and a second esophageal stethoscope 400 series 18fr was inserted. They were labeled #1 and #2 respectively. At the end of the procedure, when both temperature probes were removed, one had a sheath and one did not. The anesthesiologist checked the patient's mouth and hypopharynx for the sheath, but it was not there. A surgeon came in and did an esophagoscopy and picked the sheath out with grabbers. The patient was on the operating room table an extra 20-30 minutes for the sheath removal.
Patient Sequence No: 1, Text Type: D, B5
[8496072]
The manufacturing facility was contacted and sent the incident device for investigation. Extensive research was conducted in order to confirm no manufacturing errors contributed to this incident. The device met all specifications in place for the device. Production processes were checked and verified to have been effectively followed by manufacturing personnel. In addition to a pull test for breaking point, thickness parameters were determined to be correct as well. All production records were reviewed and found to be conforming with no discrepancies noted during final inspection. The root cause of the problem experienced could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613793-2009-00001 |
| MDR Report Key | 1571683 |
| Report Source | 06,07 |
| Date Received | 2009-12-28 |
| Date of Report | 2009-08-03 |
| Date of Event | 2009-07-21 |
| Date Facility Aware | 2009-07-21 |
| Report Date | 2009-08-03 |
| Date Mfgr Received | 2009-08-03 |
| Date Added to Maude | 2010-07-28 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer G1 | DEROYAL CIENTIFICA DE LATINOAMERICA SA |
| Manufacturer Street | GLOBAL PARK, 602 PARKWAY BOX 180-3006 |
| Manufacturer City | LA AURORA, HEREDIA 146 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 146 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL ESOPHAGEAL STETHOSCOPE 400 SERIES |
| Generic Name | ESOPHAGEAL STETHOSCOPE |
| Product Code | BZT |
| Date Received | 2009-12-28 |
| Model Number | NA |
| Catalog Number | 81-040418 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | POWELL TN 37924 US 37924 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-12-28 |