MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE 3.8C 11.6T 1050L FWJ

Model Number EG-3490K

Device Problems Obstruction of Flow (2423); Device Damaged by Another Device (2915)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

No patient is hurt!!! rest of accessory in operation channel.We try to find out which accessory and if the use of this accessory is allowed with our scope.This event occurred at the time of during use.

Manufacturer Narrative

Correction information g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result additional information h4:device manufacture date evaluation summary the used accessory is not allowed for the scope.Accessory has 4,2mm, the channel of the scope only have 3,5mm.This does not fit.The scope has been repaired.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE 3.8C 11.6T 1050L FWJ
• 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: 12701561
• MDR Text Key: 281385126
• Report Number: 9610877-2021-01421
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131902
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-3490K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1