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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 150L
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FORCEPS WINDOW REUSABLE 1.8DIA 150L Back to Search Results
Model Number KW-1815S
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.
 
Event Description
Pentax medical became aware of a report for an event which occurred in the usa stating, " we are having some issues with the biopsy forceps/graspers.They open and close just fine when not in the scopes working channel, but we have noticed during duodenoscopies where the scope is retroflexed that the forceps won't open in the animal." involving pentax forceps model kw-1815s/lot unknown.No further information was provided at the time of the report.The device was returned to pentax.Pentax replaced the device for the customer under order (b)(4).
 
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Brand Name
PENTAX
Type of Device
FORCEPS WINDOW REUSABLE 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 Key12351893
MDR Text Key283147946
Report Number9610877-2021-00537
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
PMA/PMN Number
K962897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 08/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberKW-1815S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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