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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 2.4DIA 150L
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FORCEPS TOOTHEDCUP REUSE 2.4DIA 150L Back to Search Results
Model Number VDK-FB-23-230-O-P-A1
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2021
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-2415s is available in the usa with 510k number k951198.Lot number is unavailable.Evaluation summary: it was caused due to an excessive force applied on the force during use.This report is being filed as part of the pentax backlog management plan.
 
Event Description
This event occurred at the time of during use.There was no report of patient harm.A third incident with our forceps.They break suddenly so big problem to remove them.They never saw forceps to break.3 cases, 3 doctors and 3 nurses different.The first had not been declared.The second i made the claim.And last week a third i await pharmacist statement.Besides, they report to me that since our forceps they have sent 5 gastroscopes to repair for performed sheath.Channel op 2.8mm.
 
Manufacturer Narrative
During pentax internal review it was discovered on september 6, 2021 that the event was not reportable but filed under mdr (9610877-2021-10255) which was submitted on july 24, 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 (9610877-2021-10255) which was submitted on july 24, 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 2.4DIA 150L
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12222570
MDR Text Key264975920
Report Number9610877-2021-10255
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-23-230-O-P-A1
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/26/2021
Initial Date FDA Received07/24/2021
Supplement Dates Manufacturer Received04/26/2021
Supplement Dates FDA Received09/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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