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

Model Number	179301
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/13/2018
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 prior to a lobectomy, when preparing the device a crack at the tip of the product was confirmed.They stopped using the device.The procedure was completed with another device.There was no patient involved.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted: the distal end of the cannula had a crack.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 cracked 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.No further actions have been deemed necessary at this time.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: 7944370
• Report Number: 2647580-2018-04863
• Device Sequence Number: 11141535
• Product Code: GCJ
• UDI-Device Identifier: 20884521081175
• UDI-Public: 20884521081175
• 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): 02/05/2019

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: 179301
• Device Catalogue Number: 179301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1