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

Catalog Number 544240

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok l clips 6/cart 84/box lot# 73k1800424 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clip fell off during usage on the patient.The clip fell off from the applier.

Event Description

It was reported that the clip fell off during usage on the patient.The clip fell off from the applier.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cartridge 544240 hemolok l clips 6/cart 84/box for investigation.Two loose closed clips were also returned.The clip cartridge and loose clips were visually examined with and without magnification.Visual examination revealed that the cartridge contained a closed clip and an intact clip.The sample appears used as there is biological material present on the clips and the cartridge.Reference files anp1900072777 investigation photos.Functional inspection was performed on the returned intact clip in the cartridge.A lab inventory clip applier was used.The clip was able to load properly into the jaws of the applier and was successfully applied to over-stressed surgical tubing.No functional issues were found with the returned clip.Reference file anp1900072777 for investigation photos.The ifu for this product, l06110 was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." a corrective action is not required at this time as there were no functional issues found with the returned intact clip.The reported complaint of "loaded clip is insecurely seated" could not be confirmed based upon the sample received.One cartridge and two loose closed clips were returned.The cartridge was returned with a closed clip and an intact clip.Upon functional inspection, the intact clip was able to properly load into the jaws of the lab inventory applier and was successfully applied to over-stressed surgical tubing.Since no functional issues were found with the intact clip returned in the cartridge, the reported complaint issue could not be confirmed.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9279314
• MDR Text Key: 170062412
• Report Number: 3003898360-2019-01327
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Catalogue Number: 544240
• Device Lot Number: 73K1800424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1