MAUDE Adverse Event Report: TELEFLEX MEDICAL TITANIUM LIGATING CLIPS; CLIP, IMPLANTABLE

Model Number IPN028169

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

Clips will not stay loaded on appliers.3 appliers tried with failure.New lot' worked.

Manufacturer Narrative

(b)(4).The device history review for the product horizon ti small 6/cart 180/box lot# 73c2100211 investigation did not show issues related to the complaint.

Manufacturer Narrative

Qn#(b)(4).The customer returned four unopened representative samples of 001200 horizon ti small 6/cart 180/box for investigation.The actual sample was not returned.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 representative samples.A lab inventory applier was used to perform functional inspection on the representative samples.The clips were unable to consistently load into the jaws of the applier properly and unable to consistently close when attached to over-stressed surgical tubing.The clips often fell out of the appliers during functional testing.After further inspection, it was determined that the jaws of the lab inventory applier had become misaligned.No issues were found with the returned clips.The customer also returned a total of (b)(4) unopened representative samples from the same lot of 001200 horizon ti small 6/cart 180/box for investigation in tc#(b)(4) and tc#(b)(4).A different lab inventory applier was used to perform functional inspection on these representative samples.All clips from the representative samples were able to properly load into the applier.The clips were able to close properly when applied to over-stressed surgical tubing.It was determined that the misaligned appliers used for the investigation of tc#(b)(4) caused the observed functional issues.No functional issues were found with the returned clips.However, no root cause could be determined since the actual sample (the clips that failed) were 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 representative samples that was returned.The actual sample was not returned.The reported complaint of "difficulty loading clip into applier" could not be confirmed based on the returned product.Four representative samples were returned.Upon functional inspection, no problems were found as clips could be loaded into the jaws of a properly aligned lab inventory applier and close when applied to over-stressed surgical tubing.No functional issues were found with the returned clips.However, no root cause could be determined since the actual samples (the clips that failed) were not returned.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

Clips will not stay loaded on appliers.3 appliers tried with failure.New lot' worked.

• Brand Name: TITANIUM LIGATING CLIPS
• Type of Device: 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: 14983165
• MDR Text Key: 303910223
• Report Number: 3003898360-2022-00279
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704624745
• UDI-Public: 34026704624745
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028169
• Device Catalogue Number: 001200
• Device Lot Number: 73C2100211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1