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

Catalog Number 544240

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The facility has communicated that device is not available for investigation.P/n 544240 is not being manufactured currently, however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and the samples were functionally inspected, and during the test issue reported "clips have moved away" was not observed in the current manufacturing process.The device history review could not be conducted since the lot number was not provided.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time, since the sample is not available is not possible to determine the source of the defect reported or to determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that after 8 months of surgery, the patient went to the emergency room for a cholangitis that required ct scan of the abdomen with mdc and subsequent admission to gastroenterology.Subsequent execution of ercp with removal of the calculations from the main biliary pathway and of two hem-o-lok clips closed, within the choleductus site, probably caused by retraction of the cystic duct and consequent migration of the same.The patient's condition was reported as fine.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• 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 27560 ; 9194332672
• MDR Report Key: 7566672
• MDR Text Key: 110002113
• Report Number: 3003898360-2018-00437
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• 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