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

Model Number OF-B206

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: ife, import for export.(b)(4).

Event Description

Pentax medical became aware of a report on 05mar2020 stating, "suction button does not return(restore) properly after use", involving pentax medical suction/balloon suction control valve, model of-b206/lot number unknown.User also stated that when using the suction button, the button is not restored and the suction continues during the procedure.If the doctor use silicone oil, this symptom is improved, but it is inconvenient to use it every time.After application of silicone oil, it is resolved for first patient, but it recurs from the second patient/test.The suction valve is used with pentax medical ultrasound upper gi video scope, model eg38-j10ut/serial number unknown.Marketing specialist in korea recommended user to use oil during procedure to alleviate the symptoms of non-suction recovery.

• Brand Name: PENTAX
• Type of Device: SUCTION/ SUCTION CHANNEL/ CONTROL 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 (temporary) ; 3 paragon drive; montvale, nj ; 4315880231
• MDR Report Key: 9925108
• MDR Text Key: 244800828
• Report Number: 9610877-2020-00071
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2020

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?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1