MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; ULTRASOUND VIDEOSCOPE

Model Number EG38-J10UT

Device Problem Poor Quality Image (1408)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

Pentax medical apac performed good faith efforts to gather additional information regarding this event and provided an email response on 24-feb-2024 for the following questions.Q1.Was the procedure for treatment or diagnostic purposes? a: diagnostic.Q2.Was the patient recalled for further screening? a: unknown.Q3.What is the current status of the patient.A: unknown.Q4.Was the product removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement? a:yes.Q5.Device current location and status? a: at facility.The endoscope will be sent in for repair.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Customer reported that during a procedure the ultrasound image was unable to be used due to the amount of interference in the ultrasound image.The procedure has been aborted.This event occurred at the time of during use.There was no report of patient harm.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

• Brand Name: PENTAX
• Type of Device: ULTRASOUND VIDEOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18882948
• MDR Text Key: 337672937
• Report Number: 9610877-2024-00018
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG38-J10UT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1