PENTAX

MDR report key: 7447412 · Received April 20, 2018

Report

Report Number: 9610877-2018-00117
Event Type: Malfunction
Date Received: April 20, 2018
Report Date: March 21, 2018
Manufacturer: HOYA CORPORATION PENTAX TOKYO OFFICE
Product Code: FDS
PMA / PMN Number: K041397
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

(B)(4). (EXEMPTION NUMBER E2015036).

Description of Event or Problem · 0

PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 21-MAR-2018 STATING THE FOLLOWING "THE FNA NEEDLE IS NOT COMING OUT THE END OF THE SCOPE PROPERLY" INVOLVING PENTAX VIDEO GASTROSCOPE ULTRASOUND-LINEAR ARRAY EG-3870UTK/SERIAL (B)(4). NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED BY THE USER. ON 21/MAR/2018, PENTAX MEDICAL ISSUE (B)(4) FOR THE RETURN OF THE UNIT FOR FURTHER EVALUATION. THE UNIT WAS RECEIVED AT PENTAX MEDICAL SERVICE ON 02/APR/2018 WHERE IT WAS INSPECTED ON 10/APR/2018. THE INSPECTOR FOUND THE FOLLOWING: UMBILICAL CABLE JUNCTION CASING BOTTOM CRACKED, PRISM SCRATCHED, ELEVATOR KNOB PLAY, ELEVATOR WASHING SOCKET CYLINDER RUBBER CHIPPED, CUSTOMER COMPLAINT NOT DUPLICATED, FAILED WET LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, FAILED DRY LEAK TEST, LEAK AT UMBILICAL CABLE JUNCTION CASING, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, UMBILICAL CABLE BUMP AT PVE SIDE, INSERTION TUBE GAUGE/DIG AT STAGE 1, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY, ULTRASOUND IMAGE HAS BROKEN CHANNEL, SUCTION TUBE MILD RESISTANCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290410	PENTAX	ULTRASOUND VIDEO GASTROSCOPE	FDS	HOYA CORPORATION PENTAX TOKYO OFFICE	EG-3870UTK

Patients

Seq	Age	Sex	Outcome	Treatment
1