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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; SUCTION/ SUCTION CHANNEL/ CONTROL VALVE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; SUCTION/ SUCTION CHANNEL/ CONTROL VALVE Back to Search Results
Model Number OF-B206
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Pentax medical was made aware on (b)(6) 2019 of an event that occurred in the operating room during use in (b)(6) within the apac region.The reported complaint that while using pentax medical ultrasound video gastroscope model eg34-j10u endoscope there are suction issues due to the suction valves keep getting stuck during the procedure involving pentax medical suction valve accessory, model of-b206 (unknown lot number).No serious injury or death of a patient or user was reported.Pentax medical has advised the customer to apply silicon oil on the o-rings of suction valves before use.No further suction issue have been reported.However, we will continue to monitor the issue.The investigation is currently in-process.
 
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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
MDR Report Key11837571
MDR Text Key280460152
Report Number9610877-2021-00079
Device Sequence Number1
Product Code ODG
Combination Product (y/n)N
PMA/PMN Number
REFER TO H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOF-B206
Device Lot NumberUNKNOWN
Date Manufacturer Received06/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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