FDA.reportPublic FDA data

MAUDE MDR 7929511

MDR report key
7929511
Report number
7929511
Event key
0
Event type
3
Date of event
2018-09-13
Date received
2018-10-03
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0SYMPHIONINSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGBOSTON SCIENTIFIC CORPORATIONPGTFG-020267542685* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-030

Event Narratives#

D

Patient 1

THE PATIENT WAS UNDERGOING AN OPERATIVE HYSTEROSCOPY WITH REMOVAL OF SUBMUCOUS MYOMA. THE MYOMA WAS EASILY REMOVED, HOWEVER THERE WAS BLEEDING FROM THE ATTACHMENT SITE. THE SYMPHION (REF (B)(4), LOT # 67542685) WAS SET UP, READY TO PROCEED BUT THEY COULD NOT GET THE TUBING TO PRIME. THE PATIENT BEGAN BLEEDING MORE HEAVILY AND THE CIRCULATING NURSE CONTACTED THE DEVICE REP WHO STATED THEY WERE EXPERIENCING AN EQUIPMENT FAILURE AND INSTRUCTED THEM TO REPLACE THE DEVICE AND TRY AGAIN. THE SURGEON INSTEAD CHOSE TO USE AN OPERATIVE HYSTEROSCOPE USING GLYCINE FOR DISTENDING MEDIUM AND A WIRE LOOP. THE SURGERY WAS SUBSEQUENTLY COMPLETED. PER THE SURGEON, OTHER THAN THE EQUIPMENT FAILURE, THERE WERE NO COMPLICATIONS RELATED TO THE PROCEDURE AND PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. ESTIMATED BLOOD LOSS: 350 CC. MANUFACTURER RESPONSE FOR INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULATOR, ENDOSCOPIC, BIPOLAR, SYMPHION (PER SITE REPORTER). THE REP INSTRUCTED THE OPERATION ROOM STAFF TO SEND THE DEVICE BACK TO THE COMPANY FOR REIMBURSEMENT.