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

Model Number GL3100

Device Problem Break (1069)

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.

• Brand Name: HEANEY UTERINE FORCEPS
• Type of Device: CLAMP, UTERINE
• Manufacturer (Section D): BECTON DICKINSON; franklin lakes NJ 07417
• MDR Report Key: 8381931
• MDR Text Key: 137700611
• Report Number: MW5084538
• Device Sequence Number: 1
• Product Code: HGC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2019

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 Number: GL3100
• Device Catalogue Number: GL3100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR