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

Model Number ED34-I10T

Device Problems Poor Quality Image (1408); Optical Problem (3001)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Low illuminance and poor quality of image.Did not meet use requirements.This event occurred at the time of during use.There was no report of patient harm.

Manufacturer Narrative

G6: follow up #1 h2: if follow-up, what type? h3: device evaluated by manufacture h6: coding changed based on the investigation result.D4: unique identifier (udi) d8: was this device serviced by a third party? h4: device manufacture date.Evaluation summary: based on what was reported, it was speculated that the rubber part of the remote button had been damaged and the electric switch inside the remote button had corroded and malfunctioned, causing problems with the operation of the remote button.Damage to the rubber part of the remote button can be caused by wear due to long-term use, contact with sharp parts of other equipment, pressing the button with the tip of a fingernail, etc., but the facility has selected a third-party repair.Therefore, it was not possible to identify it.The scope was repaired by the third party and returned to the hospital.

• Brand Name: PENTAX
• Type of Device: VIDEO DUODENO SCOPE
• 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 ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 15921625
• MDR Text Key: 308074942
• Report Number: 9610877-2022-00666
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K163614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

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: ED34-I10T
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1