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

Model Number	IPN915186
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Anemia (1706); Hypovolemia (2243)
Date of Event	03/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) 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 or Problem Description
It was reported that "following surgical intervention with terminal ileostomy, upon awakening the patient was in hemorrhagic shock with acute anemia.We proceed with the emergency relaparotomy finding active arterial bleeding of the ileocolic peduncle at the level of the well positioned and well closed hem-o-lock clips.We proceed with suturing with a transfixed stitch of "prolene" suture, without remove the hem-o-lock, achieving complete haemostasis.A report is sent for a suspected defect or malfunction of the medical device".The patient's current condition is reported as "fine".

• Brand Name: HEMOLOK XL 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19226120
• Report Number: 3003898360-2024-00414
• Device Sequence Number: 8320808
• Product Code: FZP
• UDI-Device Identifier: 34026704625216
• UDI-Public: 34026704625216
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2024

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: IPN915186
• Device Catalogue Number: 544250
• Device Lot Number: 73E2300621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown