MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C

Model Number EG-3670URK

Device Problem Unintended Movement (3026)

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

Event Date 10/19/2021

Event Type  malfunction  

Event Description

The time of event is unknown.There was no report of patient harm.Video image failure.

Manufacturer Narrative

We checked the returned unit and confirmed that the ccd image failure.Based on the result, we concluded that it was caused due to the ccd module defect.In addition, we confirmed that the operation channel leak, the objective lens broken, the lcb cover glass broken, and the suction channel leak; however, these are not related to the alleged complaint.Based on the technical report, it was evaluated to submit mdr.

• Brand Name: PENTAX
• Type of Device: RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka1-1-10; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12702313
• MDR Text Key: 281384461
• Report Number: 9610877-2021-50182
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 10/27/2021

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: EG-3670URK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1