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

Model Number EG36-J10UR

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2022

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax endoscope model eg36-j10ur.In the event reported, the user stated that the device have no water 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

This device is classified as import for export, therefore 510k is not applicable.There is a similar model eg36-j10ur-us available for sale in the united states with a 510k #k200090.The device was returned to pentax for further evaluation on service order (b)(4) where the user narrative was confirmed.The device was repaired where all defects found was remediated and returned to the user 16feb2022.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

During pentax internal review, the same event was filed under mdr (9610877-2022-50847) which was submitted.Therefore, mdr (9610877-2022-00328) filed on (b)(4) 2022 is considered a duplicate report.

• Brand Name: PENTAX
• Type of Device: DIGITAL RADIAL 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: 13559347
• MDR Text Key: 296392853
• Report Number: 9610877-2022-00328
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333239535
• UDI-Public: 04961333239535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG36-J10UR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1