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

Model Number	ED34-I10T
Medical Device Problem Codes	Fracture (1260); Loose or Intermittent Connection (1371); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model ed34-i10t-us is available in the usa with a 510k number k163614.Evaluation summary it was caused due to an excessive force applied on the light guide fiber bundle (lcb).In addition, we confirmed that the operation channel buckle, the segment looseness, the body cover grip broken, the u/d and the r/l pulley wires worn out, and the deflector operating knob broken; however, there are not related to the alleged complaint.Replaced parts in this complaint are as follow.Operation channel angle wire deflector wire bending rubber deflector stay tube segment light guide fiber bundle (lcb) body cover grip u/d pulley wire r/l pulley wire deflector operating knob.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Video image is dark - fibers brocken.Lcb broken, reduced.

• 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: 12222428
• Report Number: 9610877-2021-10213
• Device Sequence Number: 19867588
• Product Code: FDT
• UDI-Device Identifier: 04961333232956
• UDI-Public: 04961333232956
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2021

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: 05/03/2021
• Initial Report FDA Received Date: 07/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1