FDA.reportPublic FDA data

MAUDE MDR 1033372

MDR report key
1033372
Report number
2936999-2008-00186
Event key
0
Event type
3
Date of event
2007-09-01
Date received
2008-04-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
HOLLY GOMES
Address
5870 STONERIDGE DR. STE. 6 PLEASANTON CA 94588 US
Phone
925-925-9254
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MON-A-THERMESOPHAGEAL STETHOSCOPE W/TEMPBZWEST18FR90042NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-04-2301. R

Event Narratives#

D

Patient 1

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.

N

Patient 1

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.