MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; J10 SERIES CAMERA

Model Number PVK-J10

Device Problem Undercorrection (4058)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Pentax video colonoscope model pvk-j10 is not distributed in the usa, therefore the pma/510(k) number is not applicable.Evaluation summary: it was caused due to an excessive force applied the focus ring.This report is being filed as part of the pentax backlog management plan.

Event Description

This event occurred at the time of before use.There was no report of patient harm.I was informed that focus could not be adjusted, and the focus ring was stuck.By moving the focus ring several times, it becomes possible to move it, but the movement is awkward.The inspection was completed successfully using a substitute, and there was no health damage (injury, etc.).

• Brand Name: PENTAX
• Type of Device: J10 SERIES CAMERA
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12222400
• MDR Text Key: 282980329
• Report Number: 9610877-2021-10091
• Device Sequence Number: 1
• Product Code: FEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 07/24/2021

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: PVK-J10
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 07/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1