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

Model Number EG38-J10UT-US

Device Problems Device Reprocessing Problem (1091); Fluid/Blood Leak (1250); Material Deformation (2976)

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 (b)(6) 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.The device was returned to pentax for further evaluation on service order (b)(4).The device was inspected where the user narrative was confirmed.The inspection findings are as follows: ultrasound connector body pin bent; customer complaint confirmed; passed wet leak test; passed dry leak test the device was repaired and returned to the user on delivery# (b)(4).Parts replaced: o-rings and seals; us connector body.The device is in the process of being repaired and will be return to the use upon completion.Parts to be replaced: o-rings and seals; o-rings and seals; light guide fiber bundle (lcb); lcb distal cover glass; bending rubber; deflector operating wire; adjusting collar; angle wire.A review of the service history indicates the device was routinely serviced at a pentax facility.On 14-oct-2021, a device history record (dhr) review for model eg38-j10ut, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 08-mar-2021 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.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

Evaluation summary: the screw on the us connector is loose and there is a gap, causing a leak.Correction information: g6: follow up #1; h2: type of follow up; h6: coding changed based on the investigation result.Additional information: d4: udi; h3: device evaluated.

• 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: 12668814
• MDR Text Key: 283832958
• Report Number: 9610877-2021-01276
• 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: 12/08/2022

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-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1