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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FORCEPS WINDOW REUSABLE 1.8DIA 180L
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FORCEPS WINDOW REUSABLE 1.8DIA 180L Back to Search Results
Model Number KW1818CS
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/27/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model kw-1818cs is available in the usa with 510k number k010740.Evaluation summary: it was caused due to an excessive force applied on the cup during use.This report is being filed as part of the pentax backlog management plan.
 
Event or Problem Description
This event occurred at the time of before use.There was no report of patient harm.When i checked the operation with sterilization before use, the cup did not open.Cannot be used for inspection.
 
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Brand Name
PENTAX
Common Device Name
FORCEPS WINDOW REUSABLE 1.8DIA 180L
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo
JA 
MDR Report Key12222497
Report Number9610877-2021-10242
Device Sequence Number19908984
Product Code ODG
UDI-Device Identifier04961333224463
UDI-Public04961333224463
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/24/2021
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
Operator of Device Health Professional
Device Model NumberKW1818CS
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/27/2021
Initial Report FDA Received Date07/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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