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

Model Number	179303
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a laparoscopic thoracoscopy procedure.The port was placed between the ribs.When the scope was removed, the cannula broke and the trocar fell into pieces and some fell into the thorax.In order to resolve the issue, pieces of the trocar were removed.However, one little piece was not found and is still in the patient.The patient outcome is reported as alive, no injury.
Additional Manufacturer Narrative
Additional information: (expiration date, lot#), evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: the cannula was broken.The obturator appeared intact.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the broken cannula may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: THORACOPORT
• 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: 7584482
• Report Number: 2647580-2018-02796
• Device Sequence Number: 14085167
• Product Code: GCJ
• UDI-Device Identifier: 10884521081185
• UDI-Public: 10884521081185
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K992288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 179303
• Device Catalogue Number: 179303
• Device Lot Number: P7K0849X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other