MAUDE Adverse Event Report: TELEFLEX MEDICAL SATINSKY CLAMP SMALL AG; CLAMP, VASCULAR

Catalog Number 354004

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

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.

Manufacturer Narrative

(b)(4).Dhr was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to statinsky clamps - however the age of the device exceeds our 10 year records retention policy.(1) sample of 354004 lot ff8 was received for evaluation.Ff8 corresponds to june of 1998.This sample is 18 years old but appears to be in good shape.Visual review of the sample prior to opening the peel pouch - noted that a silicone tip protector has been placed over the ratchets.Further review after opening noted that the silicone protector has been damaged and dented in multiple locations across its length.Though it causes no damage to the device- it should be noted that this is not the correct use for a tip protector.The silicone tip protector was removed from the ratchets and the device was closed to the last ratchet.The jaws are fully closed with the last ratchet engaged.The handles were sharply impacted on a flat surface to test the retention of the other remarks: ratchet which held firmly.A rolled rubber glove was then placed in the jaws to test the security of the grip.The ratchets were fully engaged and the test material was pulled with excessive force.The jaws retained the material with no movement.The handles were sharply impacted on a flat surface to test retention under load and did not release.The jaws were then disengaged, and the test material was examined for trauma.No perforations or punctures were evident in the thin rubber glove @ 10x magnification when stretched to twice its length.The jaws and ratchets function as expected with no concerns noted.Additional testing was performed with the silicone tip protector placed over the ratchets.In the "as received" configuration the silicone protector prevents proper engagement of the ratchet.The ratchet will stop at the dented regions of the silicone and immediately slip back to the torn region when under load.Based on the complaint description and the damaged noted to the protector- it is highly likely that this foreign element was present during the procedure.Tip protection is not mentioned in any revision of the ifu.Ring handles should be open and disengaged during cleaning.This device was not sterilized according to ifu parameters prior to return.I was unable to replicate the failure mode without the presence of the silicone tip protector.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

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: SATINSKY CLAMP SMALL AG
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6147312
• MDR Text Key: 61512127
• Report Number: 3011137372-2016-00353
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 354004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death