MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; GAS/ WATER FEEDING VALVE

Model Number OF-B194

Device Problem Sticking (1597)

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

Event Date 10/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a report for an event which occurred in (b)(6) stating "3 co2 valves became stuck during the examination and too much co2 got into the patient.This has occurred with 2 patients with copd, who have become sick." pentax (b)(4) requested additional information from the customer and return of the valves for evaluation.Additional information was received stating the user uses only water, no oil or other lubricant on the valves.

• Brand Name: PENTAX
• Type of Device: GAS/ WATER FEEDING 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: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 7123153
• MDR Text Key: 95769575
• Report Number: 9610877-2017-00686
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K850020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2017,11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: OF-B194
• Device Lot Number: 0061086
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2017
• Distributor Facility Aware Date: 11/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2017
• Date Manufacturer Received: 11/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1