MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C

Model Number EG-3870UTK

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

Pentax medical became aware of a report for an event which occurred in the united states stating, " elevator broken.No angulation" involving pentax model eg-3870utk, serial number (b)(4).The timing and location of the observance is unknown.Additional information has been requested but has not been provided.The customer owned endoscope has not been received by pentax medical for evaluation under (b)(4) as of 03-sep-2021.Model eg-3870utk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.The investigation is in-process.

Manufacturer Narrative

(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: customer reported elevator broken (no angulation).Therefore, we checked the returned unit and confirmed that the deflector body loosened.Based on the result, we concluded that it was caused due to the excessive force applied on the deflector body.In addition, we confirmed that the eog valve broken, the lg cable connector scratched, the deflector operating knob grinding, and the body cover grip scratched; however, they are not the main cause, and/or irrelevant to the alleged complaint.

• Brand Name: PENTAX
• Type of Device: LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C
• 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: 12425804
• MDR Text Key: 280591154
• Report Number: 9610877-2021-00783
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333135899
• UDI-Public: 04961333135899
• 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: User Facility
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-3870UTK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1