MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030805L
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during right hepatic lobectomy, the stapler cut but did not fire.It was reported the surgeon able to squeezed the handle.No staples visible on right hepatic vein or inferior vena cava, there did seem to be some staples left in the cartridge.It was noted the patient had blood loss of 500ml or more due to the product issue.The patient had blood transfusion of 8 units of blood and 2500cc of cell-saver, the surgical time extended 30 minutes or more and the patient had extended hospitalization stay of 10 days.Suturing was done to resolve the issue.
Event or Problem Description
According to the reporter, during an extended right hepatic lobectomy procedure, while the device was being applied to the right hepatic vein at the junction with the suprahepatic vena cava, the surgeon was able to squeeze the handle and the stapler cut but did not fire.It was noted that there were no staples visible on the hepatic vein, but some staples were left in the cartridge.Suturing was done and the patient was transfused with 8 units of blood and 2500cc of cell-saver, which resulted in an extended hospital stay of 10 days.There was more than 500cc of blood loss and the surgical time was extended for more than 30 minutes.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Nicks were observed on the knife blade.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.Additionally, the investigation detected a secondary condition of damaged knife that has no relationship to the reported condition.No further actions have been deemed necessary at this time.Replication of the observed secondary damage may occur if the instrument is applied over an obstruction.The instructions for use also states: when positioning the instrument on the application site ensure that no obstructions such as previously clips are incorporated into the instrument jaws.Firing over an obstruction may result in improperly formed staples.Improperly formed staples may result in leakage or disruption of the staple line.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8341780
• Report Number: 2647580-2019-00850
• Device Sequence Number: 13487749
• Product Code: GDW
• UDI-Device Identifier: 10884523003765
• UDI-Public: 10884523003765
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K900129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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 Model Number: 030805L
• Device Catalogue Number: 030805L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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: Hospitalization; Required Intervention