MAUDE Adverse Event Report: INTEGRA JARIT COHEN ACORN CANNULA; INTERUTERINE PROBE

Model Number 505-230

Device Problem Detachment Of Device Component (1104)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2017

Event Type  Injury  

Event Description

Patient admitted for laparoscopy/d and c, patient discharged the same day.Patient presented to facility the following day reporting a foreign body fell out of her vaginal canal upon bearing down for a bowel movement.Foreign body believed to be tip of cannula used in procedure on previous day.Tip connects to surgical equipment with luer lock and disconnected inside the vaginal canal.

• Brand Name: COHEN ACORN CANNULA
• Type of Device: INTERUTERINE PROBE
• Manufacturer (Section D): INTEGRA JARIT; york PA 17402
• MDR Report Key: 6800805
• MDR Text Key: 83030494
• Report Number: MW5071632
• Device Sequence Number: 1
• Product Code: LKF
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505-230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2017
• 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): Hospitalization
• Patient Age: 32 YR
• Patient Weight: 98