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

Model Number EC38-I10F2

Device Problems Partial Blockage (1065); Collapse (1099); Failure to Disconnect (2541)

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

Event Date 10/15/2022

Event Type  malfunction  

Event Description

There is a brush stuck in the op-channel this event occurred at the time of during reprocessing.There was no report of patient harm.

Manufacturer Narrative

This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: based on the provided photograph of the inside of the pipeline of the aircraft, it was determined that the operation channel had buckled and blocked the pipeline, causing the cleaning brush to become stuck during reprocessing.

• Brand Name: PENTAX
• Type of Device: VIDEO COLONOCOPE - 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: 15664790
• MDR Text Key: 306789868
• Report Number: 9610877-2022-00582
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC38-I10F2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1