MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; DIGITAL LINEAR ULTRASOUND SCOPE

Model Number EG38-J10UT-US

Device Problems Break (1069); No Display/Image (1183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Good faith efforts were made with no additional being provided as of 18-jan-2022.The user facility has not responded to good faith effort requests for additional information as of 13-jan-2022.The customer owned endoscope was assigned rma (b)(4) but has not been received by pentax medical for evaluation as of 18-jan-20212.Model eg38-j10ut-us, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a complaint which occurred in the united states.The customer reported that there was no video image involving pentax medical ultrasound video gastroscope model eg38-j10ut-us, serial number (b)(4).The issue was observed in the operating room during use.There was no report of patient injury, delay in procedure or an event that required medical intervention.

Manufacturer Narrative

Evaluation summary: patient involved - no known adverse events.Refer to expiration date as complaint notification date.Customer reported no video image.The customer stated that no accessory was used during the procedure and there were no patient/user injuries, adverse events, delay or medical intervention reported.Tier 2 however, there was no repair data that could determine the cause.We checked the returned unit and confirmed that the objective lens unit dirty.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility on the objective lens unit.In addition, we confirmed that the us connector cable buckled; however, it is not the main cause, and/or irrelevant to the alleged complaint.

• Brand Name: PENTAX
• Type of Device: DIGITAL LINEAR ULTRASOUND 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 13283260
• MDR Text Key: 284181965
• Report Number: 9610877-2022-00045
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG38-J10UT-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1