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

Model Number EE17-J10

Device Problem No Display/Image (1183)

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

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export.Therefore, 510k is not applicable.Model ee-1580k is available in the usa, with a 510k number k961564.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed, that the ccd module with drive pcb blackout.Based on the result, we concluded that it was caused, due to the physical damage applied on the ccd module with drive pcb.Based on the technical report "hr-rpt-0586(image failure)" and/or the risk analysis results, it was evaluated to submit mdr.

Event Description

The time of event is not during procedure.There was no report of patient harm.Video image failure(blackout).

• Brand Name: PENTAX
• Type of Device: VIDEO ESOPHAGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 16758945
• MDR Text Key: 313524439
• Report Number: 9610877-2023-53614
• Device Sequence Number: 1
• Product Code: GCL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 04/18/2023

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: EE17-J10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1