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

Model Number EG29-I10

Device Problems No Display/Image (1183); Dent in Material (2526)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to pentax for further evaluation on service order (b)(4) where the user narrative was not confirmed.The inspection findings are as follows: air/ water socket o-ring chipped, passed dry leak test, passed wet leak test, customer complaint not duplicated, middle light carrying bundle distal cover glass cracked, body root brace cracked.The device was repaired where all defects found was remediated and return to the user on delivery (b)(4).On 01-dec-2021, a device history record (dhr) review for model eg29-i10, (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 06oct2017 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.

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax video scope eg29-i10.In the event reported, the user states there was no video image.The timing of the event is unknown.There was no adverse event reported with this complaint.No other information provided with this complaint.

Manufacturer Narrative

Evaluation summary: customer reported no video image.However, there was no repair data that could determine the cause.We checked the returned unit and confirmed that the light guide cable crushed.Based on the result, we concluded that it was caused due to the physical damage applied on the light guide cable.

• 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: 12951164
• MDR Text Key: 285708126
• Report Number: 9610877-2021-01683
• 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

• Date FDA Received: 12/07/2021
• 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: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Date Device Manufactured: 10/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1