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

Model Number EG-3490K

Device Problems Partial Blockage (1065); Break (1069); Failure to Disconnect (2541); Device Damaged by Another Device (2915)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a complaint on 08-dec-2020 under rma notification (b)(4) for an "accessory stuck in scope" involving the pentax medical video gastroscope, model eg-3490k, serial number (b)(4).The user also reported the stent had broken off.The user facility responded to a gfe request via email on 15-dec-2020 and again on 23-dec-2020, and stated the endoscope was being used for treatment.A boston scientific pancreatic pigtail stent and was taken out by a endochoice rat tooth grasper.No serious injury or death of a patient or user was reported.The endoscope was removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement the customer owned endoscope was received by pentax medical for evaluation on 16-dec-2020.During evaluation of the endoscope under service order (b)(4), the pentax medical service repair technician found an "accessory stuck in primary operation channel" confirming the customer's complaint and documenting the following additional findings on 21-dec-2020: primary operation channel blocked, passed dry leak test, passed wet leak test, distal body chip at channel opening at thinnest part, umbilical cable single buckled under pve root brace, hole in # 1 remote control button cover, hole in # 2 remote control button cover.The device underwent repairs including the following components: distal end assy with tubes, o-rings and seals, angle wire assy, adjusting collar, bending rubber, remote control button, light guide cable, o-ring (1.8x19.8).Instructions for use(ifu), includes the following warning section "after using operational/cleaning accessories (e.G., forceps, needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope's instrument/suction channel.Furthermore, ensure that any therapeutic devices (e.G., clips, stents, etc.) passed through the channel are accounted for after use.On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.Pentax medical model eg-3490k, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 29-mar-2013.The endoscope is awaiting repair and approved by final qc as 07-jan-2021.

Manufacturer Narrative

Correction information: h6: coding changed, based on the investigation result.Evaluation summary: this is an event, in which a foreign matter, such as a brush clogs the pipe.The cause is thought to be, that the brush used by the user, during cleaning was broken and remained in the pipe.Pentax has added a method for alerting and detecting in ifu in the event, and also implemented field action.

• Brand Name: PENTAX
• Type of Device: 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: 11135699
• MDR Text Key: 270162577
• Report Number: 9610877-2021-00025
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333147731
• UDI-Public: 04961333147731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• 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: EG-3490K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2013
• 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