MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE

Model Number EG29-I10

Device Problem Failure to Eject (4010)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

This device is not distributed in us so that unique identifier is blank.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

The user found that the watter nozzle could not use normally.This event occurred at the time of during use.There was no report of patient harm.

Manufacturer Narrative

This device is not distributed in us so that unique identifier is blank.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

The user found that the watter nozzle could not use normally.This event occurred at the time of during use.There was no report of patient harm.

Manufacturer Narrative

Evaluation summary: water/air knob rubber ring was broken.Water/air knob rubber ring was consumable.After soaking in disinfectant for a long time, it would expand, deform or be damaged, resulting in unable to use.

• Brand Name: PENTAX
• Type of Device: IMAGINA GASTROSCOPE
• 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: 12776125
• MDR Text Key: 286251122
• Report Number: 9610877-2021-01508
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1