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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS QUICKCLIP PRO-SINGLE USE; HEMOSTATIC METAL CLIP FOR THE GI TRACT

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OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS QUICKCLIP PRO-SINGLE USE; HEMOSTATIC METAL CLIP FOR THE GI TRACT Back to Search Results
Model Number HX-202UR
Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2019
Event Type  malfunction  
Event Description
During egd in icu, tech could not get any of the 4 clips to deploy.There was issues with advancing the clip out of the sheath and issues getting clips to open / close and deploy.Fda safety report id# (b)(4).
 
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Brand Name
OLYMPUS QUICKCLIP PRO-SINGLE USE
Type of Device
HEMOSTATIC METAL CLIP FOR THE GI TRACT
Manufacturer (Section D)
OLYMPUS CORPORATION OF THE AMERICAS
MDR Report Key9285856
MDR Text Key165465214
Report NumberMW5090897
Device Sequence Number1
Product Code PKL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/01/2019
4 Devices were Involved in the Event: 1   2   3   4  
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 Expiration Date05/31/2022
Device Model NumberHX-202UR
Device Lot Number96K 95K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/05/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age67 YR
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