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

Model Number	ED-3490TK
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International medical device regulators forum (imdrf) adverse event reporting (b)(4).
Event or Problem Description
Pentax medical was made aware of a complaint on 01-dec-2020 of "resistance primary biopsy channel" with the reporter stating "something stuck inside" found during reprocessing after the current procedure, involving the pentax medical video duodenoscope, model ed-3490tk, serial number (b)(4).No serious injury or death of a patient or user was reported.Three good faith effort(gfe) email requests were sent to the user facility, 28-oct-2020, 02-nov-2020 and again on 05-nov-2020, with no additional information being provided.The customer owned endoscope was received by pentax medical for evaluation on 15-oct-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 27-oct-2020: biopsy inlet t-piece stuck accessory at aft tube, passed dry leak test, prism scratched, passed wet leak test, distal cap/ case cracked, image mild spot, fluid invasion not observed in control body, fluid invasion not observed in pve connector, prism glass glue missing.The device underwent repairs including the following components: o-rings and seals, air/water tube, deflector operating wire, deflector staycoil, operation channel, bending rubber, distal case/cap, objective prism 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.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) 2017.The endoscope was delivered to the customer on 30-nov-2020 under delivery order (b)(4).

• Brand Name: PENTAX
• Common Device Name: VIDEO DUODENOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 11205364
• Report Number: 9610877-2021-00009
• Device Sequence Number: 2270855
• Product Code: FDT
• UDI-Device Identifier: 04961333229611
• UDI-Public: 04961333229611
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: D305419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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
• Operator of Device: Health Professional
• Device Model Number: ED-3490TK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1