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

Model Number EG29-I10

Device Problems No Display/Image (1183); Material Split, Cut or Torn (4008)

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

Event Date 11/17/2021

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, the user states there was no video/error msg,.The timing of the event is in unknown.There was no adverse event reported with this complaint.No other information provided with this complaint.

Manufacturer Narrative

The device was returned to pentax for further evaluation on service order (b)(4) where the user narrative of no video image was confirmed.The inspection findings are as follows: light carrying bundle has less than 70% transmission, passed dry leak test, bending rubber glue pinhole, passed wet leak test, customer complaint confirmed, image distortion and audible noise when plugged to processor, hole in # 2 remote control button cover.The device is in the process of being repaired where all defects found will be remediated and return to the user upon completion.On 07-dec-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 12sep2016 under normal conditions, passed all required inspections, and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: customer reported no video/error msg, scope not conn.The sales rep stated they are getting a message stating 'scope not supported'.Tier 2 however, there was no repair data that could determine the cause.We checked the returned unit and confirmed that the light guide fiber bundle (lcb) was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the light guide fiber bundle (lcb).Correction information: g6: follow up #1, h2: type of follow up, 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: 12974946
• MDR Text Key: 286242341
• Report Number: 9610877-2021-01693
• 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: 10/24/2022

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-I10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 10/24/2022
• Date Device Manufactured: 09/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1