MAUDE Adverse Event Report: TELEFLEX MEDICAL (PILLING-WECK SUBSIDIARY OF TELEFLEX) PILLING SATINSKY CLAMP; CLAMP, VASCULAR

Catalog Number 354004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Death (1802); Occlusion (1984)

Event Date 10/25/2016

Event Type  Death  

Event Description

Patient was undergoing living donor right liver procurement.The patient underwent hand-assisted laparoscopic mobilization of the right liver, followed by hilar dissection and parenchymal division.The right liver was removed after ligation and division of the right hepatic artery and the right portal vein, occlusion of the right hepatic vein with a vascular clamp, followed by division of the right hepatic vein.The right liver allograft was passed off the operative field to be flushed and prepared for implantation.Almost immediately afterward, the staff surgeon noticed that the right hepatic vein stump had slipped out of the clamp.The lumen of the cava was visible indicating that the donor had sustained a large air embolism.

• Brand Name: PILLING SATINSKY CLAMP
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL (PILLING-WECK SUBSIDIARY OF TELEFLEX); 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 6128498
• MDR Text Key: 60929418
• Report Number: 6128498
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/14/2016

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?: No
• Device Operator: Physician
• Device Catalogue Number: 354004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2016
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death