MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS 6/CART 84/BOX; LIGATING CLIPS

Catalog Number 544240

Device Problems Melted (1385); Migration or Expulsion of Device (1395)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The event is reported as: the clips were placed during a pyeloplasty due to the patient having a horse shoe shaped kidney with abnormal vessels.One of the clips got embedded in the renal wall (half in and half out) and may have migrated through the suture post procedure but the surgeon was not 100% sure of this.The clip was spotted during a ureteroscopy.The doctor did not know what it was and attempted to use a holium laser on it but stopped as soon as he saw the clips was melting.Patient's condition listed as clinically fine.

Manufacturer Narrative

No sample or lot# is available for investigation.Complaint cannot be confirmed since the sample was not available for investigation, therefore, it is not possible to determine a root cause for the defect reported and a corrective action for it.A dhr could not be performed due to lack of lot#.The manufacturer will continue to monitor and trend relating complaints.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: LIGATING CLIPS
• Manufacturer (Section D): TELEFLEX MEDICAL; tecate ; MX
• Manufacturer Contact: elaine burkle ; p.o. box 12600; durham, NC 27709 ; 9194334957
• MDR Report Key: 3755944
• MDR Text Key: 19295071
• Report Number: 3003898360-2014-00114
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2014

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: Other
• Device Catalogue Number: 544240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/13/2014
• 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: Initial
• Patient Sequence Number: 1