MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; SUCTION/ SUCTION CHANNEL/ CONTROL VALVE FOR EG34-J10U

Model Number OF-B206

Device Problems Physical Resistance/Sticking (4012); Suction Failure (4039)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Pentax medical became aware of a report on 09dec2019 stating, "while using the scope, suction automatically becomes active without pressing suction button.This symptom occurs intermittently.", involving pentax medical suction/balloon suction control valve, model of-b206/lot number unknown.Pentax medical asia pacific obtained the following information: "automatic suction" symptom is working without push suction valve (of-b206) and mostly right after using suction valve.It seems that after using suction valve the valve doesn't return to normal position.'silicone oil' was applied to the suction valve (of-b206).There is no serious injury or death of a patient or user reported.

• Brand Name: PENTAX
• Type of Device: SUCTION/ SUCTION CHANNEL/ CONTROL VALVE FOR EG34-J10U
• 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: 9941117
• MDR Text Key: 242607581
• Report Number: 9610877-2020-00072
• 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: 12/09/2019

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
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: No
• 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