MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-04-23 for MON-A-THERM EST18FR 90042 manufactured by .
[17762611]
During a request for product info the caller stated that in 2007 a staff crna was doing a case cervical discectomy. They noticed the tip of the probe in the surgical space. The case was discontinued and a thoracic surgeon came in and stated there was a linear tear in the esophagus and repaired the tear. Cervical area was closed and pt returned to floor. The caller stated pt is doing fine and pt had completed discectomy in later surgery.
Patient Sequence No: 1, Text Type: D, B5
[17912599]
Repeated calls have been made to the hospital to gain further info including a lot number and to determine if this incident was previously reported by other staff member(s) in 2007. In 2007, a similar call was received from an anesthesia nurse reporting to be from the same hospital. The nurse reported the end user (a surgeon) was working in the same area as the esophagus during an operative procedure. During the procedure the pt developed a perforation of the esophagus, however, it was not caused by the esophageal stethoscope. No other info was provided. Follow-up calls were made to the hospital and we requested the esophageal stethoscope be returned for our eval. No device was returned. A lot number was provided and the mfr's review found no nonconformance for the lot. In response to this recent call, we made several attempts to contact the hospital anesthesia and risk management and there has been no response. Although at this time without a lot number, or add'l info from staff we can not be absolutely certain this recent reported info is a duplicate, however, we believe it is. If we received any new significant info from the hospital, or the device is returned for our investigation, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2008-00186 |
| MDR Report Key | 1033372 |
| Report Source | 05,06 |
| Date Received | 2008-04-23 |
| Date of Report | 2008-03-27 |
| Date of Event | 2007-09-01 |
| Date Mfgr Received | 2008-03-27 |
| Date Added to Maude | 2008-05-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HOLLY GOMES |
| Manufacturer Street | 5870 STONERIDGE DR. STE. 6 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9254634612 |
| Manufacturer G1 | COVIDIEN/FORMERLY TYCO HEATHCARE |
| Manufacturer Street | AVENIDA HENEQUEN 1181 PARQUE INDUSTRIAL SALVACA |
| Manufacturer City | JUAREZ, CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MON-A-THERM |
| Generic Name | ESOPHAGEAL STETHOSCOPE W/TEMP |
| Product Code | BZW |
| Date Received | 2008-04-23 |
| Model Number | EST18FR |
| Catalog Number | 90042 |
| ID Number | RX200803-4503 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1002590 |
| Manufacturer Address | AVENIDA HENEQUEN HENEQUEN JUAREZ CHIHUAHUA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-04-23 |