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

Catalog Number 544230

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "according to the user, there was a possibility that a clip might have fallen into the abdominal cavity during surgery and it might have remained in the patient.No harm to the patient was reported." additional information states that "the clip fell out of the applier when the applier was taken out of the abdominal cavity." there were not any attempts made to retrieve the clip from the patient's cavity as "the user searched in the operative field, but could not find the clip".The patient status is reported as "fine".

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17540601
• MDR Text Key: 321065733
• Report Number: 3003898360-2023-01218
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1