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

Model Number OF-B206

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the (b)(6) involving pentax accessories suction valves been very sticky.In the event reported, it was stated the suction valves have been very "sticky", and that it is impacting his procedures.He finds that he is having to remove them each time during procedures and dip them in water to have them not be stuck in a "down" position.There was no adverse event reported with this complaint.No other information provided with this complaint.

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.The manufacture reviewed the complaint and notified the user that condition like this complaint case occur when silicon oil is not properly applied to the valves.Dhr cannot be performed since a lot number was not provided.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information: h6: coding changed, based on the investigation result.G4: premarket identification pma/510(k): model of-b206 is a suction valve, so there is no 510k number.Evaluation summary: although, the cause was investigated, the reason why it could not be used could not be identified.The assumed cause is deterioration of the o-ring, due to silicone oil.

• Brand Name: PENTAX
• Type of Device: SUCTION VALVE
• 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12923181
• MDR Text Key: 285988795
• Report Number: 9610877-2021-01706
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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
• Device Operator: Health Professional
• Device Model Number: OF-B206
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1