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
(b)(4).
Event or Problem Description
The customer owned device was previously returned to pentax medical from a customer on 20-may-2021 and inspection of the unit was performed under service order (b)(4) where the quality control inspector documented the following codes on 21-may-2021: distal cap - fixed type failed epoxy seal integrity inspecton, insertion tube bump at end of root brace, image spots, distal cap/ case cracked, primary operation channel resistance, bending rubbersevere discoloration, middle lcb distal cover glass glue is missing, failed dry leak test, suction tube resistance, segment steel braid loose, umbilical cable buckle at umbilical connector side, failed wet leak test, leak at biopsy channel (large/ primary) distal side, light carrying bundle distal cover glass middle chipped, prism scratched, distal tip annual maintenance.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, lcb distal cover, objective prism assy, 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, air/water supply tube lg, suction channel lg, light guide cable, o-ring(0.5x1.3) imp-1.Model ed-3490tk, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on 29-feb-2016.The endoscope is pending repair or approval by final qc as of 15 -jun-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: 12012207
• Report Number: 9610877-2021-00137
• Device Sequence Number: 4637306
• 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: 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): 05/21/2021

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: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/16/2021
• 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