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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE Back to Search Results
Model Number EG-2990I
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(exemption number e2015036).
 
Event Description
Pentax medical was made aware of a complaint on (b)(4) 2017 which stated 'cannot put brush in - blocked' for video gastroscope model eg-2990i/serial (b)(4) received through the pentax medical service department.No other information was provided at the time of the report.The video gastroscope was returned to pentax medical for evaluation.The pentax endoscope technician confirmed a screw stuck inside biopsy inlet port causing blockage in the primary channel.This finding confirmed the customer's complaint.Other inspectional findings included: -dry/wet leak tests failed.-leak at air/water nozzle.Pentax service confirmed the screw was a pentax part.The channel and biopsy barrel needed to be removed from the t-piece to remove the pentax screw.In addition, pentax service stated the pentax screw was somehow dropped into the t-piece during repair and during final assembly, the biopsy barrel was attached trapping the screw.Pentax medical contacted the facility to gather additional information.A response was received from the initial reporter on 27-nov-2017 stating the event occurred on (b)(6) 2017 when the physician became aware of the blockage during the procedure prior to any accessory being utilized.The blockage was discovered when the physician was unable to place biopsy forceps down the channel due to resistance.The gastroscope was removed immediately when the blockage was discovered and sent into pentax for service.No injury or issues occurred with the patient.The facility also confirmed that this was the first time the gastroscope was used for a procedure since received from pentax for a previous repair on 19-oct-2017.In addition, the gastroscope was high level disinfected prior to being used for the first time on (b)(6) 2017.Pentax medical replaced the following components on the video gastroscope involved in the event: -o-rings and seals.-distal end assy with tubes.-adjusting collar.-bending rubber.-distal attaching plate.-segment assy attaching screw.-segment attaching screw.-angle wire.-r/l and u/d pulley assy.-a/w supply tube retaining collar.-rl lock knob retaining nut cover.The video gastroscope was returned to the customer on 20-nov-2017.
 
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Brand Name
PENTAX
Type of Device
VIDEO GASTROSCOPE
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 Key7145752
MDR Text Key96115773
Report Number9610877-2017-00683
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/26/2017,11/27/2017
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 Physician
Device Model NumberEG-2990I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/26/2017
Distributor Facility Aware Date11/27/2017
Event Location Other
Date Report to Manufacturer12/26/2017
Initial Date Manufacturer Received 11/27/2017
Initial Date FDA Received12/26/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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