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

Model Number EG-3870UTK

Device Problems Break (1069); Failure to Align (2522); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

Pentax medical issued rma (b)(4) for the device to be returned for further evaluation, the device is currently pending return.On 16-dec-2021, a device history record (dhr) review for model eg-3870utk, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on (b)(6) 2008 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 (b)(6) region involving pentax video ultrasound scope eg-3870utk.In the event reported, the user states that they are having issues with the 70k series linear eus scopes.Specifically, the fna needle is missing the elevator when it exits the scope.There was no adverse event reported with this complaint.No other information provided with this complaint.

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed that the distal body chipped.Based on the result, we concluded that it was caused due to the physical damage applied on the distal body.In addition, we confirmed that the operation channel cut, the remote control buttons leaky, the lg cable connector fluid damage, the control body fluid damage, the remote control buttons leaky, and the objective prism 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: 13191107
• MDR Text Key: 285047018
• Report Number: 9610877-2022-00018
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2023

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: 12/08/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 01/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1