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

Model Number	EG29-I10
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Writer took a clean gastroscope from the cupboard and when sterile water was flushed through a dark colored fluid came out.Writer called in raymond (one of unit managers) and showed the fluid.This event occurred at the time of before use.There was no report of patient harm.
Additional 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.H4: device manufacture date.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: pentax medical 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
• Common Device Name: 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: 15974514
• Report Number: 9610877-2022-00672
• Device Sequence Number: 17606987
• Product Code: FDS
• UDI-Device Identifier: 04961333232536
• UDI-Public: 04961333232536
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EG29-I10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown