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

Model Number	179309
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2019
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 a lung resection, after the third firing, when attempting to remove the reload out of the thoracic cavity through a port, the removal failed.When checking with the camera, the jaws part of the reload was found to be broken.The cartridge was removed along with the trocar together and the issue was solved.After removal, the staple line was checked and no problem was found.Another reload, which was taken out for the next firing, was considered to be unable to be fired with the reported handle.The procedure was completed by using another device.The surgical time was extended by less than 30 min.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: that only the obturator was received.There were signs of use.There were stains on the obturator but no other abnormalities were noted.The cannula was not received so functional evaluation was precluded.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have 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: 9189106
• Report Number: 2647580-2019-05167
• Device Sequence Number: 16846774
• 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): 12/17/2019

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 Expiration Date: 09/30/2023
• Device Model Number: 179309
• Device Catalogue Number: 179309
• Device Lot Number: P8K1822Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1