MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C

Model Number EG-3870UTK

Device Problem No Display/Image (1183)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Similar model eg36-j10ur-us is available in the usa with a 510k number k200090.(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-3870utk.In the event reported, it was stated that there was no video image.The timing of this anomaly is not known.There was no adverse event reported with this complaint.The device was returned to pentax medical on service order (b)(4) where it was evaluated and the user narrative was confirmed.Additional findings are as follows: fluid invasion to insertion tube; fluid invasion in ultrasound connector; forward body frame corroded; image distorted passed wet leak test; fluid invasion in control body; elevator washing socket cylinder rubber chipped; pve electrical pin corroded; ccd circuit board corrosion; air/ water socket cylinder o-ring chipped; endoscope failed electrical safety test - plct; passed dry leak test pve electrical connector frame has severe corrossion; dust inside middle lcb distal cover glass glue; endoscope failed electrical safety test - hi-pot; ultrasound connector cable dent/ crush; up staycoil corroded; right staycoil corroded; left staycoil corroded; down staycoil corroded; staycoil holder bracket cover corroded; down angle wire corroded; up angle wire corroded; ultrasound connector casing mild discoloration; fluid invasion in pve connector; eus cable single/ long buckled at junction root brace; ultrasound connector cable single/ long fluid invasion ultrasound connector cable short fluid invasion; corroded ultrasound connector body; customer complaint confirmed; left angle wire corroded; fluid invasion in umbilical light guide cable; elevator washing socket cylinder cylinder nut missing; shield cover corroded control body corroded; fluid damage to light carrying bundle; core holding plate corroded; staycoil holder bracket corroded; ultrasound image has broken channel; right angle wire corroded.The device is currently pending repair and will be returned to the user upon completion.Parts to be replaced is as follows:o-rings and seals; deflector operting wire; adjusting collar; ud pulley assy; rl pulley assy; angle wire; connecting receptacle us connector body pb-free; switch base plate no1&no2; switch base plate no3&no4; shield cover; lg cable connector assy pb-free/nt; pcb for ccd k3a pb-free/ntsc; deflector washing socket base nut; intermediate plate; bracket cover; staycoil holder bracket; bending rubber; lcb distal cover glass a review of the service history indicates the device was routinely serviced at a pentax 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).

• Brand Name: PENTAX
• Type of Device: RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C
• 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: 12448959
• MDR Text Key: 283494477
• Report Number: 9610877-2021-00626
• 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-3870UTK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 10/19/2022
• Date Device Manufactured: 08/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1