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

Model Number EG-3870URK

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250)

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

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

The device was return to pentax for further evaluation on service order 3137968 where the user narrative was not confirm.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax endoscope model eg-3670urk.In the event reported, the user stated that the device have no air flow.The event timing is unknown.There was no adverse event reported with this complaint.No other information provided with this complaint.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed that the us connector body leakage.Based on the result, we concluded that it was caused due to the physical damage applied on the us connector body.In addition, we confirmed that the insertion flexible tube (ift) bump, the us probe eus image no scanline, the us connector cable buckled, the sub connector (us) loose, and the lcb distal cover glass cracked ; however, they are not the main cause, and/or irrelevant to the alleged complaint.

• Brand Name: PENTAX
• Type of Device: RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C
• 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: 13559342
• MDR Text Key: 296388978
• Report Number: 9610877-2022-00320
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333123360
• UDI-Public: 04961333123360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

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: EG-3870URK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1