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

Model Number EG-3870UTK

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a complaint on (b)(6) 2020 reporting that during the procedure, the needle biopsy came out of the side elevator instead of straight, involving pentax medical ultrasound video gastroscope, model eg-3870utk, serial number (b)(4).A good faith effort follow up response was received from the customer via email on 03-jan-2020.The reported stated that the accessory needle was a 22 gauge acquire fine biopsy needle.There confirmed there was no serious injury or death of a patient or user, and there was no delay in the procedure which would require medical intervention.The customer owned ultrasound gastroscope was received by pentax medical for evaluation on 06-jan-2020.The ultrasound gastroscope was inspected by pentax medical service on 07-jan-2020, and the technician documented the fna needle is coming out of the elevator body not aligned, which confirmed the customer's complaint.Other pentax medical service inspection findings included the following operation channel- primary slice by accessory, passed dry leak test, passed wet leak test, control body grip scratched, ultrasound image has broken channel, pve connector housing scratched.Repairs were performed on the ultrasound gastroscope which included replacement of the following components: o-rings and seals, operation channel, bending rubber.On (b)(6) 2020, a device history record(dhr) review was performed under ivai-20-010050, the dhr review confirmed the endoscope was manufactured on 20-feb-2015 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 for 20-feb-2015.Pentax medical ultrasound video gastroscope, model eg-3870utk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was shipped to the customer on 13-may-2015.Investigation in-process.

• Brand Name: PENTAX
• Type of Device: ULTRASOUND VIDEO GASTROSCOPE
• 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: 9653788
• MDR Text Key: 195070021
• Report Number: 9610877-2020-00036
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-3870UTK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1