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

Model Number	EG17-J10
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is classified as import for export; therefore, 510k is not applicable.Model: eg-1690k is available in the usa with a 510k number: k131902.We checked the returned unit and confirmed that the air/water channel clogged.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility on the air/water channel.In addition, we confirmed that the control body fluid damage, the u/d pulley wire fluid damage, the r/l pulley wire fluid damage, the light guide fiber bundle (lcb) broken, the operation channel buckled, and the air/water nozzle clogged; however, they are not the main cause and/or irrelevant to the alleged complaint.Based on the technical report, "hr-rpt-0630(air/water & jet water channels)" and/or the risk analysis results, it was evaluated to submit mdr.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Air/water tube clogged.

• Brand Name: PENTAX
• Common Device Name: VIDEO 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
• MDR Report Key: 16172971
• Report Number: 9610877-2023-50296
• Device Sequence Number: 2661154
• Product Code: FDS
• UDI-Device Identifier: 04961333245987
• UDI-Public: 04961333245987
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 01/16/2023

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: EG17-J10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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