MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER G.I.SCOPE

Model Number EG-2990I

Device Problems Device Contamination with Body Fluid (2317); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When pretesting a gastroscope pre procedure, nurse (b)(6), flushed water, using the foot pedal, through the forward water jet channel.She noticed several brown flecks but could not determine if they looked like blood, stool, rust etc.This event occurred at the time of before use.There was no report of patient harm.

Manufacturer Narrative

Evaluation summary: based on the contents of the report and the following confirmation results, it was assumed that the reprocessing process on the facility side was inadequate.Confirmation result: hoya checked the pipeline of the complained product that had dark colored water, but nothing was discharged and there was no abnormality in the pipeline.It is possible that the wastewater after reprocessing was stored in the cabinet in an insufficient state.

• Brand Name: PENTAX
• Type of Device: VIDEO UPPER G.I.SCOPE
• 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: 15974460
• MDR Text Key: 308396848
• Report Number: 9610877-2022-00673
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333228478
• UDI-Public: 04961333129492
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-2990I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1