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

Model Number EE17-J10

Device Problems Erratic or Intermittent Display (1182); Optical Distortion (3000)

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

Event Date 10/11/2021

Event Type  malfunction  

Event Description

Image disturbance during angulation.Also with test pcb.This event occurred at the time of during inspection.There was no report of patient harm.

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.This device is classified as import for export, therefore 510k is not applicable.

Manufacturer Narrative

Correction information g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result additional information h4:device manufacture date evaluation summary the device has been repaired and the ccd has been replaced.

• Brand Name: PENTAX
• Type of Device: VIDEO ESOPHAGOSCOPE
• 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: 12716519
• MDR Text Key: 284524705
• Report Number: 9610877-2021-01316
• Device Sequence Number: 1
• Product Code: GCL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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: EE17-J10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization