FDA.reportPublic FDA data

MAUDE MDR 4787986

MDR report key
4787986
Report number
2518897-2015-00008
Event key
0
Event type
3
Date received
2015-05-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANASTASIA VLAMIS
Address
3 PARAGON DRIVE MONTVALE NJ 07645 US
Phone
201-201-2015
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PENTAXBIOPSY FORCEPS WITH WINDOWS AND SPIKEHOYA CORPORATIONGCLKH-2422SR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-200

Event Narratives#

D

Patient 1

PENTAX MEDICAL RECEIVED A REPORT FROM A TERRITORY MANAGER ON (B)(6) 2015 STATING "DURING PROCEDURE, WHEN TRYING TO GRAB A BIOPSY IN THE PATIENT, THE HANDLE SNAPPED FROM THE BIOPSY FORCEPS. ANOTHER BIOPSY FORCEPS WAS USED TO COMPLETE THE BIOPSY". THIS EVENT OCCURRED WITH 2 SEPARATE BIOPSY FORCEPS. THE SECOND EVENT IS CAPTURED UNDER REPORT # 2518897-2015-00008. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO THE TERRITORY MANAGER ON (B)(4) 2015. THE TERRITORY MANAGER INDICATED THE PRODUCT IS AVAILABLE FOR RETURN, AND ALSO STATED VIDEO GASTROSCOPE MODEL EG-2990K WAS BEING USED AT THE TIME THE EVENT OCCURRED. A THIRD GOOD FAITH EFFORT ATTEMPT REGARDING PRODUCT RETURN WAS SENT TO THE TERRITORY MANAGER ON (B)(4) 2015. THE PRODUCT IS CURRENTLY PENDING RETURN TO PENTAX MEDICAL FOR EVALUATION. A CORRECTIVE ACTION REQUEST WILL ALSO BE SUBMITTED TO THE MANUFACTURER TO INVESTIGATE THE PRODUCT MALFUNCTION.