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

Model Number EG29-I10C

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Blocked Connection (2888)

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 a complaint which occurred in the united states within the pai region stating "no video/error msg, scope not conn." involving pentax medical video gastroscope model eg29-i10c, serial number (b)(4).There was no report of death, serious injury or other significant/important medical event.The loaner endoscope was received by pentax medical for evaluation on 31-aug-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician noted image blackout confirming the customer complaint and also documented the following inspection findings on 22-sep-2021: passed dry leak test, pve electrical connector frame has severe corrossion, passed wet leak test, light carrying bundle bundle has less than 70% transmission, fluid invasion in pve connector.The endoscope is awaiting repair and approved by final qc.Model eg29-i10c, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On 09-sep-2021, a device history record(dhr) review for model eg29-i10c, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 04-feb-2020 under normal conditions.The device was reworked including adhesive repainting for an identified hole at the tip.The endoscope passed all required inspections, and was released accordingly.Also, there were no concessions and the dates of approval for shipment and actual date shipped were confirmed for 04-feb-2020.

Manufacturer Narrative

Evaluation summary: the probable cause, was that the processor was not recognizing the scope.And the pcb failed, due to water ingress etc.Presumed.Correction information: h6: coding changed, based on the investigation result.

• 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: 12515250
• MDR Text Key: 283678436
• Report Number: 9610877-2021-00827
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333237586
• UDI-Public: 04961333237586
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190805
• 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: 12/06/2022

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: EG29-I10C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1