PENTAX KH-2422S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-20 for PENTAX KH-2422S manufactured by Hoya Corp..

Event Text Entries

[19090850] 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 # (b)(4). Good faith effort attempts were made to the territory manager on (b)(6) 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)(6) 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518897-2015-00007
MDR Report Key4788005
Report Source07
Date Received2015-05-20
Date of Report2015-04-27
Date Facility Aware2015-04-27
Report Date2015-05-19
Date Reported to FDA2015-05-19
Date Reported to Mfgr2015-05-19
Date Mfgr Received2015-04-27
Device Manufacturer Date2014-10-01
Date Added to Maude2015-05-22
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANASTASIA VLAMIS
Manufacturer Street3 PARAGON DRIVE
Manufacturer CityMONTVALE NJ 07645
Manufacturer CountryUS
Manufacturer Postal07645
Manufacturer Phone2015712300
Manufacturer G1HOYA CORPORATION
Manufacturer Street2-7-5 NAKA-PSJAO, SHINJUKU-KU
Manufacturer CityTOKYO 161-8525
Manufacturer CountryJA
Manufacturer Postal Code161-8525
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENTAX
Generic NameBIOPSY FORCEPS WITH WINDOWS AND SPIKE
Product CodeGCL
Date Received2015-05-20
Model NumberKH-2422S
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age6 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOYA CORP.
Manufacturer AddressTOKYO JA


Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-20

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