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

Model Number	ED34-I10T2
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model ed34-i10t2-us is available in the usa with a 510k number k192245.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Pentax medical was made aware of a complaint on 29-jun-2021 that occurred (b)(6) in the pai region.The endoscope failed to provide an image when connected to the video processor.Possible out of box failure involving pentax medical video duodenoscope model ed34-i10t2, serial number (b)(4).Pentax medical customer service added the text "failed connection to processor" to the rma notification.The device was sent to a local distributor for analysis and is now pending return to pentax medical for evaluation.The loaner endoscope is part of a 522 study and has not been received by pentax medical for evaluation as of 27-jul-2021.The investigation is in-process.
Additional Manufacturer Narrative
Evaluation summary: the scope failed to provide image when connected to the video processor.Possible out of box failure.Description of any actions taken: this scope was not use on any procedure because it failed during image test with a processor.(b)(6) will recommend to dr.(b)(6) or his staff to send the scope to the local pentax distributor, (b)(4).Therefore, we checked the returned unit and confirmed that the ccd module failure.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the suction channel resistance, and the ccd module intermittent; however, they are not the main cause, and/or irrelevant to the alleged complaint.Correction information: g6: follow up #1.H2: if follow-up, what type? h3: device evaluated by manufacturer? h6: coding changed based on the investigation.Additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Common Device Name: VIDEO DUODENOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0012 ; JA
• 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: 12235246
• Report Number: 9610877-2021-00230
• Device Sequence Number: 17046920
• Product Code: FDT
• UDI-Device Identifier: 04961333240135
• UDI-Public: 04961333240135
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: Health Professional
• Device Model Number: ED34-I10T2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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