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

Model Number	IPN915182
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Biliary Leak (4820)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3003898360-2023-00043
• Device Sequence Number: 5473505
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown