MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI SMALL 6/CART 180/BOX; CLIP, IMPLANTABLE

Catalog Number 001200

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product horizon ti small 6/cart 180/box, lot# 73f1900148 investigation did not show issues related to complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a clip got twisted (occurred scissoring) at ligation during an operation.Therefore, a new unit was used instead.No clip fell/remained in the patient.

Manufacturer Narrative

(b)(6).The customer returned one cartridge 001200 horizon ti small 6/cart 180/box for investigation.The clip cartridge was visually examined with and without magnification.Visual examination of the returned cartridge revealed that there were 2 clips remaining in the cartridge.The clip applier was not returned.Functional inspection was performed on the returned sample.A lab inventory clip applier was used.Both remaining clips were able to properly load into the jaws of the applier and were both successfully applied to over-stressed surgical tubing.No functional issues were found with the returned clips.It is possible that the reported issue of "clip got twisted at ligation" was caused by using damaged/misaligned appliers, but this could not be confirmed since the applier was not returned.The ifu for this product, l02428, 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 sample.The reported complaint of "not applying clip properly" was not confirmed based upon the sample received.Upon functional inspection, both remaining clips were able to properly load into the jaws of a lab inventory applier and were both successfully applied to over-stressed surgical tubing.No damages were observed to any of the returned clips.It is possible that the reported issue of "clip got twisted at ligation" was caused by using damaged/misaligned appliers, but this could not be confirmed since the applier was not returned.Since no functional issues were found with the returned clips and the applier was not returned, the reported issue could not be confirmed.

Event Description

It was reported that a clip got twisted (occurred scissoring) at ligation during an operation.Therefore, a new unit was used instead.No clip fell/remained in the patient.

• Brand Name: HORIZON TI SMALL 6/CART 180/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9934073
• MDR Text Key: 187026453
• Report Number: 3003898360-2020-00328
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001200
• Device Lot Number: 73F1900148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1