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

Model Number ED-3490TK

Device Problem 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 23-nov-2020 under rma notification (b)(4) for a "brush stuck/broken in channel - something stuck in scope" found during reprocessing, involving pentax medical video duodenoscope model ed-3490tk, serial number (b)(4) at (b)(6).The user facility replied via email to a good faith effort email on 08-dec-2020 stating an unknown plastic stent became stuck in the endoscope and was unable to be removed even though the endoscope was the appropriate size to allow the stent to pass.The endoscope was removed from service after the incident and returned to pentax medical for evaluation.The stent model and serial were not provided.No additional information was provided.The customer owned endoscope was received by pentax medical for evaluation on 11-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 14-dec-2020: a 62 insertion tube polyurethane damaged at segment side under the root brace, up/ down control knob/ lever markings faded, right/ left control knob markings faded, right/ left brake knob markings faded, passed wet leak test, primary operation channel crimped at biopsy inlet t-piece, passed dry leak test, fluid invasion not observed in control body, fluid invasion not observed in pve connector, segment compressed.The device underwent repairs including the following components: o-rings and seals, air/water tube, deflector operating wire, deflector staycoil, operation channel, adjusting collar, bending rubber, segment attaching screw, distal case/cap, distal case attaching screw, insertion flexible tube, segment assy attaching screw, staycoil collar, segment staycoil assy imp-c/pb-free, rl pulley assy, ud pulley assy, o-ring(0.5x1.3) imp-1.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 ed-3490tk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on (b)(6) 2016.The endoscope is awaiting repair and approved by final qc as of 21-dec-2020.

• Brand Name: PENTAX
• Type of Device: VIDEO DUODENOSCOPE
• 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: 11051666
• MDR Text Key: 255316222
• Report Number: 9610877-2020-00260
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333229611
• UDI-Public: 04961333229611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D305419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2020

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: ED-3490TK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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