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

Model Number	ED-3490TK
Medical Device Problem Codes	Device Reprocessing Problem (1091); Residue After Decontamination (2325)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Pentax medical was made aware of an event on 04-sep-2020 that occurred after reprocessing in the united states.The reported complaint that there is potential endoscope contamination as the endoscope failed adenosine triphosphate(atp) test 3 times after reprocessing, involving pentax medical video duodenoscope, model ed-3490tk, serial number h110912.No patient involvement was reported.The video duodenoscope was received by pentax medical for evaluation on 14-sep-2020.The video duodenoscope is currently awaiting repair, and organic sampling as of (b)(6) 2020.On 22-sep-2020, a device history record(dhr) review for model ed- 3490tk, serial number (b)(4) was performed under ivai-20-090019, the dhr review confirmed the endoscope was manufactured on 28-jan-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 28-jan-2016.Pentax medical, 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 investigation is in-process.
Additional Manufacturer Narrative
Evaluation summary: three failed atp tests after endoscope reprocessing reported possible contamination.However, the atp test is a measure of cleanliness and could not confirm bacterial or viral contamination.The dhr stated that it passed all required ] obtain culture test results in november 2022.It was confirmed that there was no risk of infection (r&d reviewed).The cause of the failure in the atp test could not be identified.Correction information: h6: coding changed based on the investigation result.

• 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
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 10624536
• Report Number: 9610877-2020-00164
• Device Sequence Number: 2719478
• Product Code: FDT
• UDI-Device Identifier: 04961333232420
• UDI-Public: 04961333232420
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: Other
• Device Model Number: ED-3490TK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown