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

Model Number EG-3870UTK

Device Problem Failure to Disconnect (2541)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event on 03-feb-2021 that occurred in the united states.We received notification from the user facility on 03-feb-2021 regarding "resistance primary biopsy channel" and the reporter also noted "wire stuck in biopsy channel" involving pentax medical linear ultrasound video gastroscope model eg-3870utk, serial number (b)(4).No additional details were provided.A good faith effort(gfe) email request for additional details was sent on 29-jun-2021.If additional information is provided, a supplemental report will be provided.The customer owned endoscope was received by pentax medical for evaluation on 09-feb-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician documented an accessory stuck in primary operation channel, accessory stuck in biopsy inlet piece, biopsy inlet t-piece stuck accessory at aft tube as well as the following inspection findings on 12-feb-2021: fluid invasion in ultrasound connector, leak at biopsy channel (large/ primary) inlet side, failed wet leak test, insertion tube abrasion, corroded ultrasound connector body, failed dry leak test, elevator washing socket cylinder rubber chipped, fluid invasion not observed in pve connector, fluid invasion not observed in control body, ccd circuit board wrong model/serial number information, right /left angulation knob play, up/ down angulation knob play, improper packing caused damage to endoscope, elevator knob play.The device underwent repairs including the following components: o-rings and seals, eus-70k series cardboard scope case, operation channel, air/water tube, bending rubber, deflector stay tube assy pb-free, deflector operting wire, adjusting collar, angle wire, deflector washing socket cylinder, us connector body pb-fre.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.Model eg-3870utk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 11-feb-2019.The endoscope was approved by final qc on 23-mar-2021 and was delivered to the customer under delivery order (b)(4).

Manufacturer Narrative

(b)(4).

• 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
• MDR Report Key: 12088478
• MDR Text Key: 281607046
• Report Number: 9610877-2021-00058
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333135899
• UDI-Public: 04961333135899
• Combination Product (y/n): N
• PMA/PMN Number: D339405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 02/03/2021

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-3870UTK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1