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

Model Number	179309
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	01/29/2018
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, during the lobectomy procedure, the device being used appeared to have no problem.However, when the device was removed from the patient, the cannula was chipped off.The surgeon searched the broken pieces in the patient¿s body with the use of an endoscope, but nothing was found.The event occurred after the procedure.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) received one device.The visual inspection of the returned product noted that the distal end of the cannula was cut.The obturator appeared intact.The condition of the device precludes functional testing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly or component related failures.Replication of the cut at the distal end of the cannula may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information becomes available, the file will be re-opened and the investigation summary will be amended as appropriate.
Event or Problem Description
According to the reporter, during the right lower thoraco/lobectomy procedure, the device was using without problem, but when the device was removed from the patient, the cannula was noted to be chipped.Surgeon searched broken pieces in the patient body with endoscope, but nothing was found.Since the event was occurred after the procedure, the operation was completed.The status of the patient: no problem.

• 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: 7261437
• Report Number: 2647580-2018-00657
• Device Sequence Number: 834753
• Product Code: GCJ
• UDI-Device Identifier: 10884521081222
• UDI-Public: 10884521081222
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: 06/30/2022
• Device Model Number: 179309
• Device Catalogue Number: 179309
• Device Lot Number: P7F1169X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 04/06/2018
• 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