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 service on 09apr2019.The ultrasound gastroscope was inspected by pentax medical service on 11apr2019, 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: image spots, fluid invasion in ultrasound connector, elevator washing socket cylinder rubber chipped, insertion tube scratches at stage 1, insertion tube buckles under the root brace, air/ water socket cylinder o-ring chipped, failed dry leak test, distal body chipped, eto vent valve loose inner shaft, umbilical cable buckle at control body side, failed wet leak test, leak at ultrasound transducer/ rubber probe, middle lcb distal cover glass glue is missing, prism glass glue cracking, ultrasound connector body deformed/bent, eus cable single/ long buckled at us connector root brace, operation channel- primary slice by accessory, corroded ultrasound connector body, fluid invasion not observed in pve connector, prism scratched, leak at # 1 remote control button cover, hole in # 1 remote control button cover, ultrasound connector cable, single/ long cracked at end of r, ultrasound transducer mild cut on probe, fluid invasion not observed in control body.Repairs were performed on the gastroscope which included replacement of the following components: o-rings and seals, segment staycoil assy pb-free, staycoil collar, insertion flexible tube, adjusting collar, operation channel, air/water channel, bending rubber, deflector stay tube assy pb-free, segment assy attaching screw, segment attaching screw, distal attaching plate, deflector operating wire, ud pulley assy, rl pulley assy, deflector washing socket cylinder, light guide cable, eog valve tightening screw imp-1, eog valve assy, remote control button (1), us connector cable body, us connector/junction cable assy pb-free, warning label, us connector body pb-free, suction channel lg, air/water supply tube lg.Investigation inprocess.Pentax model eg-3870utk/(b)(4) has been routinely serviced at pentax facility since the device was shipped to the customer on 06/25/2010.

• 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: 8522521
• MDR Text Key: 142653923
• Report Number: 9610877-2019-00269
• 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: 04/09/2019
• 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?: Yes
• 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