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U.S. Department of Health and Human Services

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

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO ENT SCOPE Back to Search Results
Model Number VNL11-J10
Device Problems Fluid/Blood Leak (1250); Material Invagination (1336)
Patient Problem Pain (1994)
Event Date 01/01/2022
Event Type  Injury  
Event Description
Comments: failed dry and wet leak test.Hole resides on the rubber tubing closest to the scope handle itself.At the distal most end of the insertion tube, the rubber started to bunch up causing a slight mushrooming of the rubber.Patients report pain and scope was taken out of service.Potential adverse event.The time of event is unknown.Date of event is unknown.
 
Manufacturer Narrative
Evaluation summary.If additional information becomes available, a supplemental report will be filed with the new information.
 
Manufacturer Narrative
Correction information b4: date of this report g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result additional information d9:device available for evaluation? e1:name and address h4:device manufacture date evaluation summary the customer owned endoscope was received by pentax medical for evaluation on 01-apr-2022.The endoscope was inspected by pentax medical service under work order (b)(4) and the service technician was able to confirm the customer complaint and documented the following inspection findings: scope leak test : dry leak test fail, scope electrical test function: dst electrical safety test fail, scope electrical test function: plct electrical safety test fail, insertion flexible tube: crushed, insertion flexible tube: fluid damage, insertion flexible tube: leak, insertion flexible tube: perforated, bending rubber: worn out, root brace rubber (insertion flexible tube): cracked, remote control button(1): cut, control body: fluid damage, control body: corroded, u/d knob: broken.The endoscope was repaired and the work order was closed on 28-apr-2022 and was delivered to the customer.A device history record(dhr) review for model vnl11-j10, serial number (b)(6) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the miyagi facility on 12-dec-2018 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 for 12-dec-2018.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
 
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Brand Name
PENTAX
Type of Device
VIDEO ENT SCOPE
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 goeller
3 paragon drive
montvale, NJ 07645
8004315880
MDR Report Key14139676
MDR Text Key289503412
Report Number9610877-2022-00482
Device Sequence Number1
Product Code EOB
UDI-Device Identifier04961333221325
UDI-Public04961333221325
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172156
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/22/2023
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? No
Device Operator Health Professional
Device Model NumberVNL11-J10
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/01/2022
Initial Date FDA Received04/19/2022
Supplement Dates Manufacturer Received04/01/2022
Supplement Dates FDA Received06/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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