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

Model Number	IPN028169
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review the product horizon ti small 6/cart 180/box lot# 73c2100211 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 even.
Event or Problem Description
In the last time clips were disposed during surgeries as the clips did not close properly.Additional information: no clip fell into the patient.The surgery was not delayed.There was no patient complications or harm.
Additional Manufacturer Narrative
(b)(4).The customer returned 2 unopened representative samples of 001200 horizon ti small 6/cart 180/box for investigation.The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that the clips appear typical.No defects or anomalies were observed.Functional inspection was performed on two of the returned representative samples.A lab inventory clip applier was used.The first 10 clips were able to properly load into the applier and were successfully applied to over-stressed surgical tubing.The applier jaws appeared to have become misaligned during testing of the 11th clip since the clip was severely misaligned when applied to the tubing.A new applier was replaced to test the last clip.The last clip was successfully applied to the tubing with no misalignment.No functional issues were found with the returned clips.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 representative samples that were returned.The actual sample was not returned.The reported complaint of "ligation failure-clip not closing" could not be confirmed based on the returned samples.Two representative samples were returned.Upon functional inspection, no problems were found as clips could be loaded into the jaws of a lab inventory applier and close with no issues.The clips were successfully attached to over-stressed surgical tubing.No functional issues were found with the returned clips.
Event or Problem Description
In the last time clips were disposed during surgeries as the clips did not close properly.Additional information: no clip fell into the patient.The surgery was not delayed.There was no patient complications or harm.

• Brand Name: HORIZON TI SMALL 6/CART 180/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12408460
• Report Number: 3003898360-2021-00848
• Device Sequence Number: 5130880
• Product Code: FZP
• UDI-Device Identifier: 24026704696349
• UDI-Public: 24026704696349
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2026
• Device Model Number: IPN028169
• Device Catalogue Number: 001200
• Device Lot Number: 73C2100211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1