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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: ife, import for export.Adverse event: international medical device regulators forum (imdrf) adverse event reporting.Health effect clinical code: no clinical signs, symptoms or conditions.Health effect impact code: no health consequences or impact.Medical device problem code: physical resistance/sticking.Component code: valve(s).Type of investigation: device not returned.Investigation findings:maintenance problem identified.Investigation conclusions: unintended use error caused or contributed to event.

Event Description

Pentax medical was made aware of an event that occurred in the operating room during use in the the (b)(6) region.The reported complaint that the pentax medical suction valve accessory, model of-b206 (unknown lot number), "does not release after suction in position 1 (suction through working channel)/ it stays fixed in suction position 1 during examination", used with pentax medical ultrasound video gastroscope model eg-38j10ut; serial number (b)(4).A user facility response to a good faith effort(gfe) was provided via email on 15-mar-2021 stating that although the technician stated there was a delay, but they did not say how long a delay.The user also said the valve would not be returned for evaluation.Lastly, when the user facility was asked if the problem exists with other valves, they stated" this issue (malfunction of suction valve) is a critical problem in nearly every sold system independent of k-series or j-10 series.This occurred the past 15 years, more or less.".Pentax medical asked the contact to inform the customer that the o-rings should be maintained for each use and silicone oil must be applied on the o-rings, before use to solve the problem.

• 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 07645 ; 8004315880
• MDR Report Key: 11631761
• MDR Text Key: 248474040
• Report Number: 9610877-2021-00080
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2021
• 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: Unknown
• Patient Sequence Number: 1