MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; LINEAR ULTRASOUND VIDEO GASTROSCOPE

Model Number EG-3270UK

Device Problem No Display/Image (1183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax video ultrasound scope eg-3670urk.In the event reported, it was stated that there was no video image.The event timing of this anomaly is unknown.There was no adverse event reported with this complaint.The device was returned to pentax medical service facility on service order (b)(4) where it was evaluated, and the user narrative was confirmed.Inspection findings are as follows: fluid invasion in control body; endoscope failed electrical safety test - plct; passed wet leak test fluid invasion in middle lcb distal cover glass; image blackout; fluid invasion in ultrasound connector; fluid invasion in segment section; pve connector housing corroded; failed dry leak test; pve electrical connector frame has severe corrosion; endoscope failed electrical safety test - hi-pot; up stay coil corroded; right stay coil corroded; left stay coil corroded; down stay coil corroded; ultrasound connector body corrosion on main circuit board; fluid invasion in pve connector; ultrasound connector casing discoloration; ultrasound connector cable single/ long fluid invasion; ultrasound connector cable short fluid invasion; corroded ultrasound connector body; fluid invasion to insertion tube; core holding plate corroded; pve electrical pin corroded; ccd circuit board corrosion; core corroded; fluid invasion in umbilical light guide cable; shield cover corroded; fluid damage to light carrying bundle; leak at elevator washing socket cylinder the device is in the process of being repaired and will be returned to the user upon completion.Parts to be replaced: o-rings and seals; staycoil collar; insertion flexible tube; deflector operating wire; deflector stay tube assy pb-free; distal attaching plate; segment assy attaching screw; bending rubber; operation channel; air/water tube; adjusting collar; connecting receptacle (1); ccd-m w/pcb assy pb-free/ntsc; light guide fiber bundle(lcb); lcb distal cover glass; us connector body pb-free; suction channel lg; air/water supply tube lg; control body complete pb-free; intermediate plate; staycoil holder bracket; bracket cover; guide cover plate; u-stopper; d-stopper; r-stopper; l-stopper; remote control wire pb-free; gnd wire; lg cable connector assy pb-free/nt; shield cover a review of the service history indicates the device is routinely serviced at a pentax service facility.No other information provided.

Manufacturer Narrative

Correction information: g6: follow up #1.H2:if follow-up, what type? h6: coding changed based on the investigation result (health effect - clinical code, health effect - impact code).Additional information: h4:device manufacture date.

• Brand Name: PENTAX
• Type of Device: LINEAR ULTRASOUND VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12453932
• MDR Text Key: 283602577
• Report Number: 9610877-2021-00628
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-3270UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 10/19/2022
• Date Device Manufactured: 06/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1