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

Model Number EG36-J10UR

Device Problem Unintended Movement (3026)

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

Event Date 01/01/2022

Event Type  malfunction  

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.

Event Description

No known adverse event.Refer to expiration date as complaint notification date.Customer reported that their facility has some difficulty with insufflating the balloon for eus scope since they have the new j10 series.A lot of frustration for nurse team and doctor are very disappointed to have to do a procedure without balloon.The time of event is unknown.There was no report of patient harm.

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.This device is classified as import for export, therefore 510k is not applicable.

• Brand Name: PENTAX
• Type of Device: ULTRASOUND VIDEOSCOPE
• 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: 15143526
• MDR Text Key: 304100611
• Report Number: 9610877-2022-00533
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333239535
• UDI-Public: 04961333239535
• 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: Physician
• 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: 08/02/2022
• 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
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1