MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS

Catalog Number 544240

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review could not be conducted since the lot number was not provided.No sample is available for investigation according to the report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the clip was no longer on the artery when the patient was reopened 10 hours after the procedure was originally completed.Large clips applied with robotic arm to cystic artery and cystic duct.The patient presented with high blood pressure shortly after surgery; medication was given.Later, the patient had much lower blood pressure.A ct scan indicated fluid in the abdomen.The patient was taken back for surgery and bleeding was found, believed to be from the cystic artery.There was not a clip on the artery, 3 clips remained on the cystic duct.Surgical intervention was required to stop the bleeding.The patient's condition was reported as fine.

• Brand Name: HEMOLOK L CLIPS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 5035666
• MDR Text Key: 24428065
• Report Number: 3003898360-2015-00572
• Device Sequence Number: 1
• Product Code: MCH
• 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
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention