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
Adverse event: international medical device regulators forum (imdrf) adverse event reporting.(b)(4).Type of investigation: testing of actual/suspected device.Investigation findings: wear problem.Investigation conclusions: cause traced to user.
Event or Problem Description
The customer owned device was previously returned to pentax medical from a customer on (b)(6) 2021 and inspection of the unit was performed under service order (b)(4) where the quality control inspector documented the following codes on 20-jan-2021: distal cap - fixed type failed epoxy seal integrity inspection, primary operation channel resistance, distal tip annual maintenance, failed dry leak test, up/ down control knob/ lever markings faded, remote control button case cracked under #2 button, leak at remote control button case, passed wet leak test, distal cap/ case cracked, fluid invasion in control body, middle lcb distal cover glass glue is missing, control body mild corrosion inside, fluid invasion not observed in pve connector, umbilical cable single buckled under pve root brace.The duodenoscope'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, bending rubber, distal case/cap, rl pulley assy, ud pulley assy, r.C button case, switch with base plate no1 pb-free, switch with base plate no2 pb-free, switch with base plate no3 pb-free, o-ring(0.5x1.3) imp-1, angle wire, o-ring (1.8x19.8), rl lock knob retaining nut cover, segment staycoil assy imp-c/pb-free, shield pipe for ccd, laser cut filter type 7.Model ed-3490tk, serial number (b)(4) , has been routinely serviced at a pentax facility since the device was put into service on 03-mar-2015.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: 11355397
• Report Number: 9610877-2021-00051
• Device Sequence Number: 4117719
• Product Code: FDT
• UDI-Device Identifier: 04961333229611
• UDI-Public: 04961333229611
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,health
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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: 01/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• 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