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

Model Number	179303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2018
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, the device was used in a segmental resection lobectomy procedure.When the surgeon used it with the stapler, he found that the distal end of the device was broken.The procedure was completed with another device.The status of the patient was reported as no problem.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the tip of the device was broken.The obturator was not received.The condition in which the device was received 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 component related failures.Replication of the broken tip of the device 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.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: 7447338
• Report Number: 2647580-2018-01964
• Device Sequence Number: 13895420
• Product Code: GCJ
• UDI-Device Identifier: 10884521081185
• UDI-Public: 10884521081185
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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 Expiration Date: 08/31/2021
• Device Model Number: 179303
• Device Catalogue Number: 179303
• Device Lot Number: P6H0420X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 06/09/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1