MAUDE Adverse Event Report: US SURGICAL PUERTO RICO VERSAPORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number ONB5STF

Device Problems Difficult to Remove (1528); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic hysterectomy and bilateral salpingo-oophorectom procedure, the device's obturator broke.The trocar that broke was the initial trocar being placed, in the umbilicus.The metal tube portion of the obturator broke loose from the hub.The metal tube was then stuck inside the cannula.Nothing fell into the patient.The surgeon then used another device to resolve the issue in order to complete the case.There was no patient injury.

• Brand Name: VERSAPORT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12011232
• MDR Text Key: 256677740
• Report Number: 2647580-2021-02052
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521134232
• UDI-Public: 10884521134232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONB5STF
• Device Catalogue Number: ONB5STF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1