MAUDE Adverse Event Report: RICHARD WOLF MEDICAL LAPAROSCOPIC INJECTION NEEDLE

Model Number RCHW NUMBER 8383.60

Device Problems Break (1069); Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/10/2017

Event Type  Injury  

Event Description

A (b)(6) female admitted on (b)(6) 2017 for laparoscopic intrafascial hysterectomy with left salpingo-oophorectomy.During the course of injecting in and around the cervix with local and epinephrine, the laparoscopic 22 gauge needle broke.The surgeon attempted to find needle fragment; however, he was not able to visually identified it.F/u x-ray showed that the object of interest had migrated even higher into the abdomen, was under the diaphragm.On (b)(6) 2017, pt returned to operating room for successfully removal of needle fragment.

• Brand Name: LAPAROSCOPIC INJECTION NEEDLE
• Type of Device: LAPAROSCOPIC INJECTION NEEDLE
• Manufacturer (Section D): RICHARD WOLF MEDICAL; vernon hills IL 60061
• MDR Report Key: 6812812
• MDR Text Key: 83535041
• Report Number: MW5071751
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RCHW NUMBER 8383.60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 84