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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 (b)(6) 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. Event problem and evaluation codes: no known impact or consequence to patient. Loss of or failure to bond. Actual device evaluated. Wear problem. Device repaired and returned.
 
Event Description
A customer device was returned to pentax medical on (b)(6) 2018 for routine service due to 522 pms study. Inspection of the unit was performed on (b)(6) 2018 where the quality control inspector found the following: distal cap - fixed type failed epoxy seal integrity inspection. Air/ water socket cylinder o-ring chipped. Passed wet leak test. Umbilical cable dent. Passed dry leak test. Customer complaint confirmed. Operation channel- primary mild resistance. The scope's repairs included the distal case/cap, which was replaced and/or resealed pursuant to the field correction, and returned to the user on (b)(6) 2018.
 
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Brand NamePENTAX
Type of DeviceVIDEO DUODENOSCOPE
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 Key7652970
MDR Text Key113247237
Report Number9610877-2018-00325
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092710
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 06/29/2018,06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberED-3490TK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/29/2018
Distributor Facility Aware Date06/22/2018
Device Age63 MO
Event Location Other
Date Report to Manufacturer06/29/2018
Date Manufacturer Received06/22/2018
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 Reuse
Removal/Correction NumberNOT ISSUED YET

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