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 20mar2019 reporting that during an endoscopic ultrasound (eus) procedure for a cyst drainage the physician observed the sheath moving off the track of the elevator to the right side involving pentax medical video gastroscope ultrasound-linear array model eg-3870utk, serial number (b)(4).The physician had the needle at zero then inserted into the biopsy channel.He then luer locked the needle onto the scope, took the sheath out to 1.5, and we could not see the sheath in the ultrasound and optic image.He took the sheath back to zero then pulled the entire scope out.The entire needle was taken out of the channel and started over on a towel to reproduce this and the same outcome happened every time.This was attempted three times and the physician had to abort the case all together.No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported by the user.On 29mar2019, pentax medical customer service issued rma # (b)(4) for the return of the unit for further evaluation.The unit was returned to pentax medical on 15apr2019.Currently pending evaluation.

• 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: 8522522
• MDR Text Key: 142653217
• Report Number: 9610877-2019-00268
• 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: 04/17/2019,03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• 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: 04/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2019
• Distributor Facility Aware Date: 03/20/2019
• Device Age: 106 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2019
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2010
• 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