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
Additional Manufacturer Narrative
International medical device regulators forum (imdrf) adverse event reporting (b)(4).
Event or Problem Description
Pentax of america initiated field correction (b)(4) 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 customer owned device was previously returned to pentax medical from a customer on 26-jan-2021 and inspection of the unit was performed under service order (b)(4) where the quality control inspector documented the following codes on 26-jan-2021: distal cap - fixed type failed seal integrity inspection, insertion tube perforation at stage 1, failed dry leak test, distal cap - fixed type distal tip upgrade, air/ water socket cylinder o-ring chipped, up/ down brake knob/ lever markings faded, right/ left brake knob markings faded, leak at insertion tube stage 1, failed wet leak test, lightguide prong cover glass set loose, endoscope failed electrical safety test - hi-pot, # 2 remote control button cover cracked, elevator knob clicking sound, umbilical cable single buckled under pve root brace, operation channel twisted in bending section, fluid invasion not observed in control body, pve electrical connector frame mild corrosion.Inspection of the seal between the distal body and distal cap was performed and the device failed the inspection criteria.The endoscope'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 stay coil, operation channel, adjusting collar, angle wire, bending rubber, segment attaching screw, distal case/cap, distal case attaching screw, insertion flexible tube, segment assay attaching screw, rl pulley assay, ud pulley assay, remote control button, deflector body link, o-ring(0.5x1.3) imp-1, o-ring (1.8x19.8), remote control button, signal wire for ccd imp-t, shield pipe for ccd.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) 20109.The endoscope is awaiting repair or approval by final qc as of 19-feb-2021.

• 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: 11355476
• Report Number: 9610877-2021-00053
• Device Sequence Number: 4117721
• Product Code: FDT
• UDI-Device Identifier: 04961333229611
• UDI-Public: 04961333229611
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Other
• Remedial Action: Recall,Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 01/27/2021

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: 01/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/19/2021
• 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