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

Model Number	ED-3490TK
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Pentax of america initiated field correction 2017-001-c which included inspection of the seal around the distal body and distal cap of the ed-3490tk duodenoscope pursuant to predefined inspection criteria (et-hf-p-0013 rev.00).The objective of the inspection was to verify there were no defects/discontinuities in the seal between the distal body and distal cap.The inspectional criteria was defined as, "all seal surfaces observed shall be continuous and smooth with no outward signs of discontinuity, gaps or bubbles." a device was considered to fail the inspection if any element of the criteria was not met.The rented endoscope was previously returned to pentax medical from a customer on 14-jun-2021 and inspection of the unit was performed under service order (b)(4) where the quality control inspector documented the following codes on 15-jun-2021: distal cap - fixed type failed seal integrity inspection, insertion tube gauge/dig at stage 1, control body root brace cut, prism scratched, air/ water socket cylinder o-ring chipped, primary operation channel resistance, distal cap/ case scratched, middle lcb distal cover glass glue is missing, failed wet leak test, suction tube resistance, failed dry leak test, distal cap - fixed type distal tip upgrade, # 2 remote control button cover cracked, prism glass glue missing, insertion tube mild crush at stage 1, bending rubber pinhole.Inspection of the seal between the distal body and distal cap was performed and the device failed the inspection criteria.The endoscop's repairs will include the distal case/cap, which will be replaced and/or resealed pursuant to the field correction, along with the following parts, and returned to the user upon completion: o-rings and seals, air/water tube, deflector operating wire, deflector staycoil, operation channel, adjusting collar, angle wire, bending rubber, distal case attaching screw, rl pulley assy, ud pulley assy, remote control button, root brace rubber lg body, suction channel lg, deflector body link, distal case/cap, o-ring(0.5x1.3) imp-1, insertion flexible tube.This is the first time pentax model ed-3490tk, serial number (b)(4) has been returned for serviced at a pentax facility since the device was put into service on 31-aug-2017.The endoscope is awaiting repair or approval by final qc as of 21-jun-2021.
Additional Manufacturer Narrative
(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: 12033343
• Report Number: 9610877-2021-00117
• Device Sequence Number: 14305801
• Product Code: FDT
• UDI-Device Identifier: 04961333229611
• UDI-Public: 04961333229611
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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
• Operator of Device: No Information
• Device Model Number: ED-3490TK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT ISSUED YET
• Patient Sequence Number: 1