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

Model Number ED34-I10T

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• 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 ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12222428
• MDR Text Key: 264967756
• Report Number: 9610877-2021-10213
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333232956
• UDI-Public: 04961333232956
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED34-I10T
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1