MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT

Device Problem Intermittent Communication Failure (4038)

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: based on the complaint description, we found that there were several products in use, which were the pc, the dell monitor, and the connection cables.From these things, we concluded that it was caused due to the connection problem between the dell monitor and the pc such as the cable disconnection which is not related to our product.This report is being filed as part of the pentax backlog management plan.

Event Description

The time of event is unknown.There was no report of patient harm.Our pentax field service engineer was onsite to install several new capture pcs, and one the dell monitors that came with them would not display a picture.Description of any actions taken: he tried multiple cables and connections and even different computers, but it would not display an image.

• Brand Name: PENTAX
• Type of Device: ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT
• 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: 12305577
• MDR Text Key: 265991011
• Report Number: 9610877-2021-10346
• Device Sequence Number: 1
• Product Code: OCS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1