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

Model Number EG38-J10UT

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

This model is classified as import for export and not distributed in the united states, therefore 510k is not applicable.We do have similar model eg38-j10ut-us available in the united states with a 510k number k200090.International medical device regulators forum (imdrf) adverse event reporting.(b)(4).This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.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 (b)(6) region reporting "us probe is leaky" involving pentax medical ultrasound video gastroscope model eg38-j10ut, serial number (b)(4).There was no report of death, serious injury or other significant/important medical event.This event is fda reportable due to the lack of information to justify that this event would not cause or contribute to a serious injury or other adverse event.

• 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: 12355854
• MDR Text Key: 268069549
• Report Number: 9610877-2021-00731
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2021

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: EG38-J10UT
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 08/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1