MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE 3.8C 2.8C 12.8T FWJ

Model Number	EG-3890TK
Medical Device Problem Codes	Product Quality Problem (1506); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
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
Air/water nozzle missing.There was no report of patient harm.The time of event is unknown.Date of event: not known for the exact date, we just know the year the complaint was sent in to manufacturer.
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 additional information h4:device manufacture date evaluation summary the device has been repaired.

• Brand Name: PENTAX
• Common Device Name: VIDEO GASTROSCOPE 3.8C 2.8C 12.8T 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: 13691945
• Report Number: 9610877-2022-00344
• Device Sequence Number: 4930581
• Product Code: FDS
• UDI-Device Identifier: 04961333152827
• UDI-Public: 04961333152827
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: EG-3890TK
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2017
• 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