MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VALVES

Model Number OF-B206

Device Problem Obstruction of Flow (2423)

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

Event Date 10/07/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax accessories air/water & suction valves been very sticky.In the event reported, it was stated the air/water and 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

Since a model was not provided, 510k cannot be determined.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 model and lot was not provided.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: the probable cause is deterioration of the o-ring, which is not coated with silicone oil.Correction information d4: model#.G6: follow up #1.H2: type of follow up.H6: coding changed based on the investigation result.Additional information d4: udi.G4: device for evaluation.H3: device evaluated.

• Brand Name: PENTAX
• Type of Device: VALVES
• 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: 12751636
• MDR Text Key: 282118262
• Report Number: 9610877-2021-01318
• Device Sequence Number: 1
• Product Code: EOQ
• 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: 12/08/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 12/08/2022
• 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