MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE - I10 STANDARD

Model Number EG29-I10

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

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 united states stating that there was "no video error message image" involving pentax video gastroscope model eg29-i10, serial number (b)(4).The customer also stated user able to white balance light in scope but not showing up on the screen.There was no report of death, serious injury or other significant/important medical event.Multiple good faith effort attempt have been made with no additional information being provided.The customer owned endoscope was received by pentax medical for evaluation on 24-sep-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint via distorted image as well as several image related components to have been fluid damaged including the following inspection findings: insertion tube buckles at end of root brace, fluid invasion in control body, fluid invasion in segment section, leak at biopsy channel (large/ primary) inlet side, failed wet leak test, endoscope failed electrical safety test - plct, segment crooked, pve electrical connector frame has severe corrosion, failed dry leak test, fluid invasion to insertion tube, fluid invasion in pve connector, primary channel resistance at proximal end near root brace, fluid damage to light carrying bundle, fluid invasion in umbilical light guide cable, ccd circuit board corrosion, control body severe corrosion inside, pve electrical pin corroded.The device underwent repairs including the following components: o-rings and seals, segment staycoil assy pb-free, staycoil collar, insertion flexible tube assy, segment assy attaching screw, segment attaching screw, bending rubber, rl pulley assy, ud pulley assy, adjusting collar, light guide fiber bundle, shield pipe for ccd, signal wire for ccd pr-free, pcb for ccd drive pb-free, remote control button(1), operation channel, lg cable connector assy pb-free.The endoscope is awaiting repairs and approved by final qc as of 16-oct-2021.Model eg29-i10, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.

Manufacturer Narrative

Correction information: g6: follow up #1.H2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result (health effect - clinical code, health effect - impact code).

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE - I10 STANDARD
• 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: 12643916
• MDR Text Key: 284178710
• Report Number: 9610877-2021-01033
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• UDI-Public: 04961333211692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1