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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON HEANEY UTERINE FORCEPS CLAMP, UTERINE

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BECTON DICKINSON HEANEY UTERINE FORCEPS CLAMP, UTERINE Back to Search Results
Model Number GL3100
Device Problems Break (1069); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2019
Event Type  Malfunction  
Event Description

During hysterectomy, heaney uterine forceps tip broke at the tooth, approximately 8 mm from the tip of the instrument, while attempting to grasp the uterus. The instrument was immediately removed from the field and the tip of the instrument was retrieved by the surgeon. The instrument and the broken tip were then examined by two rn¿s in the room, and determined that both pieces fit firmly together with no missing pieces.

 
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Brand NameHEANEY UTERINE FORCEPS
Type of DeviceCLAMP, UTERINE
Manufacturer (Section D)
BECTON DICKINSON
franklin lakes NJ 07417
MDR Report Key8381931
MDR Text Key137700611
Report NumberMW5084538
Device Sequence Number1
Product Code HGC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGL3100
Device Catalogue NumberGL3100
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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