MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO DUODENOSCOPE - I10 STANDARD

Model Number	ED34-I10T
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model ed34-i10t is available in the usa with a 510k number k163614.Evaluation summary it was due to an excessive force applied on the accessory while inserting and withdrawing from the operation channel.In addition, we confirmed that the defector wire break, the deflector body damage, the objective prism assy break, the lcb distal cover glass break, the u/d and r/l pulley wires stretch, and the deflector operation knob break; however, these are not related to the alleged complaint.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
Date of event not known for the exact date, we just know the year the complaint was sent in to manufacturer.This event occurred at the time of reprocessing.There was no report of patient harm.Accessory stuck in scope.

• Brand Name: PENTAX
• Common Device Name: VIDEO DUODENOSCOPE - I10 STANDARD
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12250883
• Report Number: 9610877-2021-10536
• Device Sequence Number: 3635860
• Product Code: FDT
• UDI-Device Identifier: 04961333232956
• UDI-Public: 04961333232956
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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: Health Professional
• Device Model Number: ED34-I10T
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1