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

Model Number	IPN914921
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During use of the device the clips do not hold and jump off (reopened).
Additional Manufacturer Narrative
(b)(4).The device history review for the product horizon ti small 6/cart 180/box, lot# 73a2200613.Investigation did not show issues related to the complaint.
Additional Manufacturer Narrative
(b)(4).The customer returned one loose clip, one empty cartridge, one lidstock, and two 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 the returned samples.A lab inventory clip applier was used.All clips were able to properly load into the applier.The clips were able to close properly when applied to over-stressed surgical tubing and did not reopen.No functional issues were found with the returned clips.It is possible that the reported issue 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 samples that were returned.The reported complaint of "ligation failure-clip reopening" could not be confirmed based on the returned samples.One loose clip, one empty cartridge, one lidstock, and two unopened 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 when applied to over-stressed surgical tubing without reopening.No functional issues were found with the returned clips.It is possible that the reported issue of "ligation failure-clip reopening" 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 or Problem Description
During use of the device the clips do not hold and jump off (reopened).

• Brand Name: HORIZON TI SMALL 6/CART 180/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14633439
• Report Number: 3003898360-2022-00223
• Device Sequence Number: 5937112
• Product Code: FZP
• UDI-Device Identifier: 34026704624745
• UDI-Public: 34026704624745
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN914921
• Device Catalogue Number: 001200
• Device Lot Number: 73A2200613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown