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

Model Number EG29-I10

Device Problem No Display/Image (1183)

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

Event Date 09/13/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the (b)(6) region involving pentax video scope eg29-i10.In the event reported, it was stated that there was no video image/error message, scope not connected.It is unknown when the anomaly was discovered.There was no adverse event reported with this complaint.The device was returned to pentax for further evaluation on service order (b)(4) and was inspected where the user narrative was confirmed.The inspection findings are as follows: insertion tube gauge/dig at stage 1; ccd circuit board corrosion; bending rubber severe discoloration; up/ down angulation knob play; left angulation decreased; right /left angulation knob play; pve electrical pin corroded; passed dry leak test; distal body chipped; endoscope failed electrical safety test - hi-pot; passed wet leak test; image blackout; pve electrical connector frame mild corrosion; suction tube twisted/kink; insertion tube mild dent at stage 2; fluid invasion in pve connector; customer complaint confirmed; hole in # 1 remote control button cover; down angulation decreased; air/ water socket cylinder o-ring chipped; core corroded; shield cover corroded; hole in # 4 remote control button cover.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; o-rings and seals; insertion flexible tube assy; distal end assy with tubes; rl pulley assy; ud pulley assy; bending rubber; adjusting collar; angle wire; pcb for ccd drive pb-free; electrical connector assy; suction channel lg.A review of the service history indicates the device was routinely serviced at a pentax facility.On 24-sep-2021, a device history record (dhr) review for model eg29-i10, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 27aug2018 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks and 1 concessions ((b)(4)) and the dates of approval for shipment and actual date shipped were confirmed.No other information provided with this complaint.

Manufacturer Narrative

(b)(4).The user narrative was not confirmed, however other defects was found which was corrected.If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: PENTAX
• Type of Device: 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: 12599045
• MDR Text Key: 283758664
• Report Number: 9610877-2021-01017
• 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: 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

• Date FDA Received: 10/08/2021
• 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: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Date Device Manufactured: 08/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1