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

Model Number PVK-J10

Device Problem Image Display Error/Artifact (1304)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

Hold for rh 1.18 per the initial report, pentax loaner scope pvk-j10 display image is moving when the root brace handle is moved.The impact is that the endoscopy image on the screen is moved and in come cases it even goes out of image frame.Sn: (b)(4).Date of event is unknown.This event occurred at the time of installation.There was no report of patient harm.

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.510k number is not applicable.

Manufacturer Narrative

Correction information: g4: premarket identification pma/510(k) g6: follow up #1 h2: if follow-up, what type? h3: device evaluated by manufacture h6: coding changed based on the investigation result.H4: device manufacture date.Evaluation summary: from the reported events, it was found that the cable of the camera head and the internal image sensor are integrated, and when the cable is shaken, the image sensor also moves at the same time, causing the image to shake.This is within the specifications of the product and is not a product failure.

• Brand Name: PENTAX
• Type of Device: VIDEO MODULE
• 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: 15974509
• MDR Text Key: 308456386
• Report Number: 9610877-2022-00656
• Device Sequence Number: 1
• Product Code: FEA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K220465
• 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: 02/09/2023

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: PVK-J10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1