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U.S. Department of Health and Human Services

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

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO DUODENOSCOPE Back to Search Results
Model Number ED-3490TK
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Based on discussion with fda on may 8, 2017, all inspectional failures are being reported as mdrs notwithstanding the fact that the presence of discontinuities, gaps or bubbles does not necessarily have either technical or clinical significance.(b)(4).(exemption number e2015036).
 
Event Description
Pentax of america initiated field correction (b)(4) which included inspection of the seal around the distal body and distal cap of the ed-3490tk duodenoscope pursuant to predefined inspection criteria ((b)(4) rev.00).The objective of the inspection was to verify there were no defects/discontinuities in the seal between the distal body and distal cap.The inspectional criteria was defined as, "all seal surfaces observed shall be continuous and smooth with no outward signs of discontinuity, gaps or bubbles." a device was considered to fail the inspection if any element of the criteria was not met.The customer owned device was previously returned to pentax medical from a customer on (b)(6) 2017 with a concern of broken lens.Inspection of the unit was performed on (b)(6) 2017 where the quality control inspector found the following: hole in #2 remote control button cover.Passed all leak test.Lightguide prong cover glass set loose.Residue on objective lens.Umbilical cable single buckled under pve root brace.Image shadows.Inspection of the seal between the distal body and distal cap was performed on (b)(6) 2017.The device failed the inspection criteria.Repairs were performed which included replacement of the following components: -remote control button -distal case/cap -rings and seals the distal case/cap was replaced and resealed pursuant to the field correction and the duodenoscope was returned to the customer on 05/25/2017.
 
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Brand Name
PENTAX
Type of Device
VIDEO DUODENOSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi
tokyo, 196-0 012
JA  196-0012
MDR Report Key6655648
MDR Text Key78067491
Report Number9610877-2017-00051
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
PMA/PMN Number
K092710
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Recall
Type of Report Initial
Report Date 06/20/2017,05/22/2017
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 No Information
Device Model NumberED-3490TK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2017
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/20/2017
Distributor Facility Aware Date05/22/2017
Event Location Other
Date Report to Manufacturer06/20/2017
Initial Date Manufacturer Received 05/22/2017
Initial Date FDA Received06/20/2017
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberNOT ISSUED YET
Patient Sequence Number1
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