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

Model Number EG38-J10UT

Device Problem Gas/Air Leak (2946)

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

Event Date 03/21/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: it was caused due to a physical damage applied on the us probe.In addition, we confirmed that operation channel buckle, the angle wire play, and deflector wire stretch; however, these are not related to the alleged complaint.This device is not marketed in us, therefore 510k is not applicable.Model eg38-j10ut-us is available in the usa with a 510k number k200090.This report is being filed as part of the pentax backlog management plan.

Event Description

The us probe is leaky.The time of event is during inspection.There was no report of patient harm.

• 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 ; 3 paragon drive; montvale; nj 07645 ; 8004315880
• MDR Report Key: 12186988
• MDR Text Key: 262171047
• Report Number: 9610877-2021-10391
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333239498
• UDI-Public: 04961333239498
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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