MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L

Model Number EG-2990I

Device Problem No Display/Image (1183)

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 "there was no video image" involving pentax medical video gastroscope model eg-2990i, serial number (b)(4).The timing and the location of the observation was not provided.There was no report of serious injury, delay in procedure or required medical intervention.The customer responded to a good faith effort attempt via email on 22-sep-2021 and stated the event occurred just prior to the procedure.No additional information was provided.The customer owned endoscope was received by pentax medical for evaluation on (b)(6) 2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint of image blackout and also documented the following inspection findings: insertion tube buckles at end of root brace, distal body chip at channel opening at thinnest part, passed wet leak test, suction tube resistance, passed dry leak test, umbilical cable single buckled under pve root brace, control body frame based plate coating peeling, ccd circuit board corrosion, ccd circuit board loose center connection.The device underwent repairs including the following components: o-rings and seals, distal end assy with tubes, adjusting collar, bending rubber, insertion flex tube, angle wire, rl pulley assy, ud pulley assy, suction channel lg.Additionally the board was resoldered.The endoscope is awaiting repair completion and approved by final qc as of 11-oct-2021.Model eg-2990i, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On 24-sep-2021, a device history record(dhr) review for model eg-2990i, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 19-oct-2010 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 20-oct-2010.

Manufacturer Narrative

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

• Brand Name: PENTAX
• Type of Device: HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L
• 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: 12609038
• MDR Text Key: 283410553
• Report Number: 9610877-2021-01015
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333129492
• UDI-Public: 04961333129492
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-2990I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1