MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C

Model Number EG-3670URK

Device Problems No Display/Image (1183); Optical Problem (3001)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax video scope eg-3670urk.In the event reported, the user states that there were 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.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

The device was returned to pentax for further evaluation on service order (b)(4) where the user narrative was confirmed.Inspection findings are as follows: ultrasound image not detected by ultrasound machine, passed dry leak test, bending rubber glue cracking at insertion tube side passed wet leak test, ultrasound connector lock handle inner lock not engaging, insertion tube mild dent at stage 3, eus cable single/ long bump at junction root brace, customer complaint confirmed.The device is in the process of being repair where all defects found will be remediated and returned to the user upon completion.If additional information becomes available, a supplemental report will be filed with the new information.

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 us probe malfunction.Based on the result, we concluded that it was caused due to the excessive force applied on the us probe.Correction information: g6: follow up #1, h2: type of follow up, h6: coding changed based on the investigation result.Additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Type of Device: RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C
• 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: 13167706
• MDR Text Key: 289072399
• Report Number: 9610877-2022-00009
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333123360
• UDI-Public: 04961333123360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• 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: 10/24/2022

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: EG-3670URK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 10/24/2022
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1