MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VALVE, AIR/WATER

Model Number	OF-B121
Medical Device Problem Codes	Unintended Movement (3026); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The valve is defective so the valve constantly insufflates air.This event occurred at the time of before use.There was no report of patient harm.
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
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.From the reported content, it was determined that air was supplied to the body through the scope even if the valve was not closed with a finger because the air release path of the air supply valve was clogged.The clogged hole is an important part that is confirmed by visual inspection, is also used in functional inspection, and is not a structure that clogs due to initial failure.In addition, each of the above inspections is carried out on all products, so it is difficult to think of manufacturing errors.From the above, it was determined that some kind of object had become stuck due to handling at the facility.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 26-sep-2022 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed on 26-sep-2022.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: VALVE, AIR/WATER
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• 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: 16275390
• Report Number: 9610877-2023-00017
• Device Sequence Number: 6766364
• Product Code: FDT
• UDI-Device Identifier: 04961333070442
• UDI-Public: 04961333070442
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K963056
• 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): 04/20/2023

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: OF-B121
• Device Lot Number: 0021092
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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