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

Model Number EGIAUSTND

Device Problems Component Missing (2306); Mechanics Altered (2984)

Patient Problems Death (1802); Blood Loss (2597)

Event Type  Death  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one handle.Visual inspection of the returned product noted that the firing knobs were retracted and the articulation lever was in neutral position.The instrument was loaded with a pmv representative reload and applied to test media.All staples were placed and the test media was cleanly transected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic total nephrectomy procedure, as the surgeon was dividing the renal artery, the stapler was fired across the renal artery.It appeared to fire normally, but there was bleeding noted right away.No staples were dispensed from the device, which resulted in an incomplete staple line.The surgeon did not see any staples in the cavity.He tried to get the bleeding under control but was unsuccessful.The surgical staff were unable to give the patient a blood transfusion due to religious beliefs.The patient coded on the or table and they were unable to revive her.

Manufacturer Narrative

Correction: udi.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA ULTRA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7330360
• MDR Text Key: 102087761
• Report Number: 2647580-2018-01299
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

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
• Device Operator: Health Professional
• Device Model Number: EGIAUSTND
• Device Catalogue Number: EGIAUSTND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 02/20/2018
• Supplement Dates FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death