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MAUDE MDR 7591181

MDR report key
7591181
Report number
7591181
Event key
0
Event type
3
Date of event
2018-05-12
Date received
2018-06-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
403
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
1GOMCOCLAMP, CIRCUMCISIONOWENS & MINORHFXR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-1201. O

Event Narratives#

N

Patient 1

D

Patient 1

THE OBSTETRICIAN WAS PERFORMING THE INFANT'S CIRCUMCISION USING A GOMCO DEVICE. THE TIME-OUT HAD OCCURRED AND THE LOCAL ANESTHESIA HAD BEEN PLACED. AFTER WAITING THE REQUIRED 5 MINUTES, THE PHYSICIAN BEGAN THE PROCEDURE. SHE PLACED THE 1.3 SIZE GOMCO CLAMP ON THE PENIS AND TIGHTENED THE KNOB IN PLACE. AFTER WAITING ANOTHER 5 MINUTES, THE PHYSICIAN BEGAN TO USE THE SCALPEL TO CUT THE FORESKIN AROUND THE GOMCO. SHE WAS APPROXIMATELY HALFWAY AROUND THE CIRCUMFERENCE OF THE PENIS WHEN THE DEVICE FELL OFF. THE DEVICE WAS READJUSTED AND THE INCISION WAS COMPLETED. THERE WAS BLEEDING AROUND THE SITE AND SILVER NITRATE WAS USED FOR HEMOSTASIS. THERE APPEARED TO BE A DEFECT IN THE SKIN OVER THE SHAFT OF THE PENIS, SO THE PHYSICIAN CONSULTED UROLOGY FOR CONSULT AND REPAIR. THE UROLOGIST CAME IN AND REPAIRED THE LACERATION WITH 2 SUTURES, AND THEN APPLIED NUMEROUS SUTURES CIRCUMFERENTIALLY TO REAPPROXIMATE THE PENILE AND PREPUTIAL SKIN. THE PROVIDER ATTEMPTED TO USE THE GOMCO DEVICE CORRECTLY, BUT INVESTIGATION OF THE INCIDENT AND THE DEVICE HAS CONCLUDED THAT WE WERE UNABLE TO DETERMINE THAT THE DEVICE FAILED. THAT BEING SAID, WE WERE CURIOUS AS TO WHY THE SCREW KNOB ON THE DEVICE CAN BE SCREWED ON BOTH RIGHT SIDE UP AND UPSIDE DOWN. THIS SEEMED LIKE A RISK TO US.