MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER G.I.SCOPE

Model Number EG29-I10

Device Problem Image Display Error/Artifact (1304)

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

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported frozen image.This event occurred at the time of before use.There was no report of patient harm.

Manufacturer Narrative

Correction information: follow up #1.If follow-up, what type? device evaluated by manufacturer.Adverse event problem: coding changed based on the investigation result.Additional information device manufacture date.Evaluation summary as a result of the investigation, it is determined that the ccd and cable are out of order due to external load.

Manufacturer Narrative

Correction information g2: report source (checked "foreign", so fixed it.) g6: follow up #2 h2:if follow-up, what type?.

• Brand Name: PENTAX
• Type of Device: VIDEO UPPER G.I.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: 15308524
• MDR Text Key: 305099795
• Report Number: 9610877-2022-00557
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• UDI-Public: 04961333211692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• 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,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1