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

Model Number EG36-J10UR

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.The device was returned to pentax for further evaluation.Since a serial number was not provided dhr was not reviewed.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 (b)(6) involving pentax video ultrasound scope eg36-j10ur.In the event reported, the user stated that the device failed leak test out of the box.The timing of the event is before delivery.There was no adverse event reported with this complaint.No other information provided with this complaint.

Manufacturer Narrative

Evaluation summary: the screw on the us connector is loose and there is a gap, causing a leak.Correction information: g4: premarket identification pma/510(k) 510k number is not applicable.G6: follow up #1 h2: type of follow up h6: coding changed based on the investigation result.D9: available for evaluation.H3: device evaluated.

• Brand Name: PENTAX
• Type of Device: ULTRASOUND GASTROSCOPE
• 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: 12951149
• MDR Text Key: 285987624
• Report Number: 9610877-2021-01677
• Device Sequence Number: 1
• Product Code: ODG
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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: EG36-J10UR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1