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

Model Number IPN915182

Device Problem Break (1069)

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.

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.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

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.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).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.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 was observed on the intact clip.No other defects or anomalies were observed.The clip breaking at the hinge during ligation was determined to be the result of insert mismatch at the hinge area of the clip.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.Dimensional inspection was not required as a part of this complaint investigation.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.Per dhr the product hemolok ml clips 6/cart 84/box lot# 73k2200590 was manufactured on 10/19/2022 a total of (b)(4) pieces.Lot was released on 11/10/2022.Dhr investigation did not show issues related to complaint.The ifu for this product, 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." the returned broken clip was broken at the hinge during ligation.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.The reported complaint of "broken/detached parts - clip - hinge" was confirmed based upon the sample received.A broken clip was returned, and it was broken at the hinge.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.Teleflex will continue to monitor and trend on complaints of this nature.The initial mdr report sent on 06 june 2023, shall be corrected to reflect the updated us fda decision tree from reportable injury with serious injury to reportable malfunction- adverse event."the segment might have still been in the patient, but the physician decided to finished the procedure." the surgeon has made a risk/benefit decision to leave part of the device in the patient and not undertake a further surgical intervention to retrieve it.The surgeon has made the decision that the risks of removing it (which requires surgical intervention which may include irreversible scarring) are greater than leaving the piece in situ, even if it results in prolonged and intense discomfort or stress which may require medical intervention.

• 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: 17070508
• MDR Text Key: 316663177
• Report Number: 3003898360-2023-00823
• 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?: Yes
• 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?: Device Not Returned to Manufacturer
• 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