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

Model Number	ONB5STF
Medical Device Problem Codes	Difficult to Remove (1528); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 12011232
• Report Number: 2647580-2021-02052
• Device Sequence Number: 4305839
• Product Code: GCJ
• UDI-Device Identifier: 10884521134232
• UDI-Public: 10884521134232
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: ONB5STF
• Device Catalogue Number: ONB5STF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1