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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Based on discussion with fda on may 8, 2017, all inspectional failures are being reported as mdrs notwithstanding the fact that the presence of discontinuities, gaps or bubbles does not necessarily have either technical or clinical significance.(b)(4).(exemption number e2015036).
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 ((b)(4) 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 (b)(6) 2017 with a concern of broken lens.Inspection of the unit was performed on (b)(6) 2017 where the quality control inspector found the following: hole in #2 remote control button cover.Passed all leak test.Lightguide prong cover glass set loose.Residue on objective lens.Umbilical cable single buckled under pve root brace.Image shadows.Inspection of the seal between the distal body and distal cap was performed on (b)(6) 2017.The device failed the inspection criteria.Repairs were performed which included replacement of the following components: -remote control button -distal case/cap -rings and seals the distal case/cap was replaced and resealed pursuant to the field correction and the duodenoscope was returned to the customer on 05/25/2017.

• 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: 6655648
• Report Number: 9610877-2017-00051
• Device Sequence Number: 473903
• Product Code: FDT
• Combination Product (Y/N): N
• PMA/510(K) Number: K092710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/22/2017
• Report Date (Section F): 06/20/2017

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: 05/18/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2017
• Event Location: Other
• Date Report to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/20/2017
• 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
• Date Report Sent to FDA: 06/20/2017