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

Model Number IPN915182

Device Problem Device Dislodged or Dislocated (2923)

Event Date 12/16/2022

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).A visual, dimensional, or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history review for the product hemolok ml clips 6/cart 84/box lot# 73h2200288 investigation did not show issues related to the complaint.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.The customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

Event Description

Reported event: the surgeon performed laparoscopic cholecystectomy on a patient.After surgery, the surgeon noticed bile spillage in the patient's body, so the follow-up surgery was performed.During the follow-up surgery, the surgeon found that one of two clips had migrated from cystic duct and another clip migrated when the surgeon touched it with an instrument.Two clips fell in the patient, but both were removed from the patient's body and the follow-up surgery was successfully finished.It was also reported that according to the surgeon necrosis of the cystic duct, or damage to the cystic duct during the first surgery, may have caused bile spillage.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Additional information received indicates the following: the spillage of bile occurred 15 days after the first surgical procedure and 10 days after discharge.The clip had fallen into the abdominal cavity in a closed state.For the second surgery, the cystic duct was sutured, no clips were used.The patient was discharged after the second surgery and his/her health is improving.

Event Description

Reported event: the surgeon performed laparoscopic cholecystectomy on a patient.After surgery, the surgeon noticed bile spillage in the patient's body, so the follow-up surgery was performed.During the follow-up surgery, the surgeon found that one of two clips had migrated from cystic duct and another clip migrated when the surgeon touched it with an instrument.Two clips fell in the patient, but both were removed from the patient's body and the follow-up surgery was successfully finished.It was also reported that according to the surgeon necrosis of the cystic duct, or damage to the cystic duct during the first surgery, may have caused bile spillage.The patient's condition was 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16229910
• MDR Text Key: 307978266
• Report Number: 3003898360-2023-00043
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• 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: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Hospitalization; Required Intervention