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

Model Number IPN915182

Device Problem Difficult to Open or Close (2921)

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

Event Date 05/12/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(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 during a laparoscopic cholecystectomy, the physician attempted to ligate the cystic duct, however the clip didn't close/lock.The physician attempted again with another clip from the same cartridge and this clip broke in two pieces and fell into the patient.One piece of the clip was found and removed, however after searching the patient's cavity the other piece of the clip was not found."the segment might have still been in the patient, but the physician decided to finished the procedure." no patient harm or injury.

Manufacturer Narrative

(b)(4).The reported complaint of "clips not closing/locking" could not be confirmed based upon the sample received.The customer returned one intact clip and half of one broken clip from one unit of 544230 hemolok ml clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.Visual examination revealed that the broken clip was broken in half at the hinge.The hook half was returned.Evidence of use in the form of biological material was observed on the returned sample.Signs of use in the form of biological material and slight damage to the pierced bosses of the intact clip was observed.No other defects or anomalies were observed.As part of functional inspection, the loose intact clip was loaded into lab inventory appliers and successfully applied to overstressed surgical tubing without breaking.Functional testing could not be performed on the broken clip because it was broken in half at the hinge.The ifu for this product 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." since no functional issues were found with the returned clips, the reported issue could not be confirmed.A dhr review was performed with no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.Additional information received on 13 june 2023 states that "a clip broke in the abdominal cavity and one of the pieces was never found.It is likely that it has fallen into the abdominal cavity.One of the clip fragments has not been found, leading to a lengthy search for it.The length of that time is unknown.After spending time searching for the clip, the surgery was terminated at the discretion of the surgeon.A new product with the same product number, 544230 was used.Postoperative ct imaging was performed.To date, there have been no reports of patient health hazards.The patient's health status is unknown.I haven't heard of any plans for another surgery.So far the retained segment of clip has not impacted the patient".The issue did not affect the patient's length of stay.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that during a laparoscopic cholecystectomy, the physician attempted to ligate the cystic duct, however the clip didn't close/lock.The physician attempted again with another clip from the same cartridge and this clip broke in two pieces and fell into the patient.One piece of the clip was found and removed, however after searching the patient's cavity the other piece of the clip was not found."the segment might have still been in the patient, but the physician decided to finished the procedure." no patient harm or injury.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17070331
• MDR Text Key: 316798195
• Report Number: 3003898360-2023-00822
• 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,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73K2200590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• 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