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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 Device Reprocessing Problem (1091)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 07/11/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).(exemption number e2015036).
 
Event Description
Pentax medical was made aware of a report which stated "black rubber piece about an inch long came out of scope and into a patient" involving pentax model eg-2990i/serial (b)(4).The video gastroscope (pentax model eg-2990i/serial (b)(4)) was returned to pentax medical for evaluation after the event occurred.The black material was also returned to pentax medical for identification.The pentax medical service inspectional findings included: -operation channel, primary mild scratch inside.-passed wet/dry leak test.-umbilical cable bump.-lightguide prong cover glass set loose.-insertion tube bump at stage 1.-insertion tube bump at end of root brace.-suction tube mild resistance.-insertion tube mild crush at stage 3.Pentax medical service confirmed the black material returned by the facility was not part of the video gastroscope.Pentax medical followed up with the facility to gather additional information.In response to the follow up, the territory manager visited the facility on 07/28/2017 to aid in the facility investigation.The facility identified the material as a piece of a boston scientific, 15-18mm cre pro wireguided balloon, model 5870.The facility stated on 07/28/2017 that no debris remained in the patient after the material was retrieved.The patient did not report any symptoms of illness after the event occurred, will not be recalled for further screening, and has since been dismissed from the hospital.During the visit, the territory manager reminded the customer on inspecting each accessory to ensure no material remains in the endoscope after use.Repairs were performed on the video gastroscope which included replacement of the following components: -o-rings and seals.-distal end assy with tubes.-adjusting collar.-bending rubber.-distal attaching plate.-segment assy attaching screw.-insertion flex tube.-angle wire.-light guide cable.The video colonoscope was returned to the customer on 08/03/2017.
 
Manufacturer Narrative
Hoya corporation pentax (b)(4), specification developer, registration no.9610877 pentax of america, inc., importer, registration no.2518897 pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax (b)(4) (exemption number e2015036).
 
Event Description
On 17-nov-2017, pentax medical received voluntary medwatch report# (b)(4) from the fda via postal mail.The voluntary medwatch described the event as follows: patient was having an egd.During the egd the physician stated that he felt like biopsy forceps was difficult to pass down the biopsy channel.After biopsy was obtained, the doctor complained that the scope was no longer able to hold air, and a black piece of rubber was seen in the patient's stomach.The piece of rubber was retrieved and was intact, removed with ease from the patient's stomach using a biopsy forceps.No harm was done to the patient.Scope was pulled out and checked and found to have a large inner channel leak and was sent to the biomed department to prepare to be sent for repair.The physician was satisfied that all rubber from the inside of the scope was removed intact from the patient's stomach.
 
Manufacturer Narrative
Hoya corporation pentax (b)(4), specification developer, registration no.9610877.Pentax of america, inc., importer, registration no.2518897 pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax (b)(4) (exemption number e2015036).
 
Event Description
On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.The instructions for use for this model endoscope instructs the user to "maintain view of the accessory during advancement, use and withdrawal of the device".A device history review was performed on 11-dec-2017 confirming the gastroscope was manufactured under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.No further information has been received for this event, therefore pentax considers this medwatch report closed.
 
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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
2015712300
MDR Report Key6788852
MDR Text Key82560446
Report Number9610877-2017-00411
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,Followup,Followup
Report Date 03/09/2018,07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEG-2990I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/09/2018
Distributor Facility Aware Date07/13/2017
Device Age67 MO
Event Location Hospital
Date Report to Manufacturer03/09/2018
Initial Date Manufacturer Received 07/13/2017
Initial Date FDA Received08/11/2017
Supplement Dates Manufacturer Received11/17/2017
11/17/2017
Supplement Dates FDA Received12/15/2017
03/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age29 YR
Patient Weight149
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