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

Model Number EG38-J10UT-US

Device Problem Device Reprocessing Problem (1091)

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

Event Date 09/23/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax video ultrasound scope eg38-j10ut.In the event reported, it was stated that water was coming from the gap when they squeeze it.The physician is worried about infection control regarding the water.The event timing is unknown.There was no adverse event reported with this complaint.Pentax medical customer service issued (b)(4) for the device to be returned for further evaluation.The device is currently pending return to pentax.No other information provided with this complaint.

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information: h6: coding changed, based on the investigation result.Evaluation summary: it is a complaint, due to the large gap in the us connector of the eus-j10 series.Although, there is a gap, the reprocessing test was passed in this state, and there is no problem.A gap that is only a problem in appearance and does not leak is regarded as a pass.So it is judged, that the specification is satisfied.

• 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: 12668837
• MDR Text Key: 284290009
• Report Number: 9610877-2021-01087
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333239436
• UDI-Public: 04961333239436
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200090
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG38-J10UT-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1