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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FORCEPS TOOTHEDCUP REUSE 1.8DIA 150L
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FORCEPS TOOTHEDCUP REUSE 1.8DIA 150L Back to Search Results
Model Number VDK-FB-18-160-O-P-A1P
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2021
Event Type  malfunction  
Manufacturer Narrative
This device is not distributed in us so that unique identifier is blank.This device is classified as import for export, therefore 510k is not applicable.Model ka-1815s is available in the usa with a 510k number k951198.Evaluation summary: it was caused due to an excessive force applied on the cap.This report is being filed as part of the pentax backlog management plan.
 
Event Description
This event occurred at the time of before use.There was no report of patient harm.When the product was opened and confirmed when it was used at the facility, the opening and closing operation was not successful, so the use was discontinued and treatment was continued with another product.In addition, since defects were confirmed in the pre-use inspection, no health damage has occurred to patients or healthcare professionals.
 
Manufacturer Narrative
During pentax internal review it was discovered on september 6, 2021 that the event was not reportable but filed under mdr (9610877-2021-10328) which was submitted on july 30, 2021.This product is not reportable because of oem products.Pentax has forwarded this complaint to the legal manufacturer.This report is being filed as part of the pentax backlog management plan.
 
Event Description
During pentax internal review it was discovered on september 6, 2021 that the event was not reportable but filed under mdr (9610877-2021-10328) which was submitted on july 30, 2021.This product is not reportable because of oem products.Pentax has forwarded this complaint to the legal manufacturer.This report is being filed as part of the pentax backlog management plan.
 
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Brand Name
PENTAX
Type of Device
FORCEPS TOOTHEDCUP REUSE 1.8DIA 150L
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12250858
MDR Text Key264516165
Report Number9610877-2021-10328
Device Sequence Number1
Product Code GCL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/15/2021
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 Health Professional
Device Model NumberVDK-FB-18-160-O-P-A1P
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/05/2021
Initial Date FDA Received07/30/2021
Supplement Dates Manufacturer Received04/05/2021
Supplement Dates FDA Received09/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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