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

Model Number EG38-J10UT

Device Problem Unintended Movement (3026)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Customer reported that their facility has some difficulty with insufflating the balloon for eus scope since they have the new j10 series.There was no report of patient harm.The time of event is before use.Not known for the exact date, we just know the year the complaint was sent in to manufacturer.

Manufacturer Narrative

Evaluation summary: during the pre-procedure check, so we asked to inspect the scopes at the pentax repair center and found that air/water port o-rings were getting chipped or damaged which was the direct cause of not insufflating eus balloons on these scopes.In a further investigation on site, it was found that the same port was getting brush cleaning as well as air drying with a powerful jet.Both were making the o-ring rubber more fragile and susceptible to breaking more frequently and easily.Pentax customer representative was able to correct this by providing user training and correct steps as per the ifu.These measures have eliminated the root cause and have been confirmed to have resolved the complaint.

• 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: 15127493
• MDR Text Key: 304514934
• Report Number: 9610877-2022-00531
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333239436
• UDI-Public: 04961333239436
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG38-J10UT
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1