MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VALVE, SUCTION

Model Number	OF-B120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number is unavailable.Evaluation summary: it was caused due to the valve worn out.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
This event occurred at the time of before use.There was no report of patient harm.The suction valve was used for half of year; the sealed ring drops and it affected function.

• Brand Name: PENTAX
• Common Device Name: VALVE, SUCTION
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12222453
• Report Number: 9610877-2021-10294
• Device Sequence Number: 11796559
• Product Code: FDF
• UDI-Device Identifier: 04961333070435
• UDI-Public: 04961333070435
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131855
• 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): 07/24/2021

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-B120
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 07/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1