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

Model Number EG-3870UTK

Device Problem Structural Problem (2506)

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

Event Date 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to pentax for further evaluation on service order 3137639 where it currently pending evaluation.On 07-jan-2022, 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 09may2014 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 endoscope model eg-3870utk.In the event reported, the user stated the device insertion tube is worn out.The event timing 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

Evaluation summary: since repair information could not be obtained, the cause of wear of the insertion portion could not be identified.A possible cause is deterioration due to chemicals during reprocessing due to repeated use.

• 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: 13385574
• MDR Text Key: 295608153
• Report Number: 9610877-2022-00148
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1