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

Model Number	ED-3490TK
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Pentax medical became aware of a report on 22apr2020, "customer stated that they received positive cultures after multiple cycles of reprocessing", involving pentax medical video duodeno scope, model ed-3490tk/serial number (b)(4).The customer owned video duodenoscope was received by pentax medical for evaluation on 17-apr-2020.The duodenoscope was inspected by pentax medical service on 21-apr-2020 and the following inspection findings were documented: distal cap - fixed type failed epoxy seal integrity inspection, passed wet leak test, passed dry leak test, hole in # 2 remote control button cover, fluid invasion not observed in pve connector, fluid invasion not observed in control body.The video duodenoscope underwent repairs including the following components: o-ring(0.5x1.3), distal case/cap, o-rings and seals, remote control button.The dhr review confirmed the endoscope was manufactured on 23-feb-2016 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for (b)(6) 2016.Pentax 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) 2016.The video duodenoscope is currently awaiting qc final approval and organic resampling as of 17-may-2020.The investigation is currently in process as of 17-may-2020.

• 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: 10065454
• Report Number: 9610877-2020-00077
• Device Sequence Number: 19026773
• Product Code: FDT
• UDI-Device Identifier: 04961333225903
• UDI-Public: 04961333225903
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: Health Professional
• Device Model Number: ED-3490TK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1